History of Changes for Study: NCT05850520

A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) (QUASAR)

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Study Record Versions

Version	Submitted Date	Changes
1	April 28, 2023	None (earliest Version on record)
2	May 16, 2023	Study Status, Contacts/Locations and Outcome Measures
3	June 5, 2023	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	July 13, 2023	Contacts/Locations and Study Status
5	August 15, 2023	Contacts/Locations and Study Status
6	September 21, 2023	Contacts/Locations and Study Status
7	October 24, 2023	Study Status and Contacts/Locations
8	November 27, 2023	Study Status and Contacts/Locations
9	December 27, 2023	Study Status
10	January 30, 2024	Study Status
11	February 29, 2024	Contacts/Locations and Study Status
12	April 3, 2024	Contacts/Locations and Study Status
13	May 14, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	22153
Brief Title:	A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) (QUASAR)
Official Title:	Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion
Secondary IDs:	2022-502174-16-00 [CTIS (EU)]

Study Status


Record Verification:	April 2023
Overall Status:	Not yet recruiting
Study Start:	May 9, 2023
Primary Completion:	November 29, 2024 [Anticipated]
Study Completion:	May 16, 2025 [Anticipated]

First Submitted:	April 28, 2023
First Submitted that Met QC Criteria:	April 28, 2023
First Posted:	May 9, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	April 28, 2023
Last Update Posted:	May 9, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Bayer
Responsible Party:	Sponsor
Collaborators:	Regeneron Pharmaceuticals

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO).

In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema.

When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry.

The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease.

Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg.

The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care.

To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have:

adverse events
serious adverse events

"Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important.

Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks.

One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study.

During the study, the study doctors and their team will:

check patients' eye health using various eye examination techniques
measure patients' eye vision (BCVA)
take blood and urine samples
do physical examinations
check vital signs
examine heart health using electrocardiogram (ECG)
do pregnancy tests in women of childbearing age

In addition, participants will be asked to fill a questionnaire on vision-related quality of life.

Detailed Description:

Conditions


Conditions:	Macular Edema Secondary to Retinal Vein Occlusion
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	822 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Higher Dose Regimen 1 Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.	Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Intravitreally (IVT) injection. Drug: Sham Sham procedure will be given on visits when an active injection is not planned. Diagnostic Test: Fluorescein Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.
Experimental: Higher Dose Regimen 2 Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.	Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Intravitreally (IVT) injection. Drug: Sham Sham procedure will be given on visits when an active injection is not planned. Diagnostic Test: Fluorescein Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.
Active Comparator: Standard of care Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.	Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg Intravitreally (IVT) injection. Diagnostic Test: Fluorescein Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.

Outcome Measures


Primary Outcome Measures:
1.	Change from baseline in BCVA measured by the ETDRS letter score at Week 36 [ Time Frame: At Week 36 ]
Secondary Outcome Measures:
1.	Number of active injections from baseline to Week 64 [ Time Frame: From baseline to Week 64 ]
2.	Number of active injections from baseline to Week 36 [ Time Frame: From baseline to Week 36 ]
3.	Change from baseline in BCVA measured by the ETDRS letter score at Week 44 [ Time Frame: At baseline, week 44 ]
4.	Change from baseline in BCVA measured by the ETDRS letter score at Week 64 [ Time Frame: At baseline, week 64 ]
5.	Number of participants gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64 [ Time Frame: From baseline at week 36 and week 64 ]
6.	Number of participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64 [ Time Frame: At week 36 and week 64 ]
7.	Participant having no IRF and no SRF in the center subfield at Weeks 36 and 64 (yes/no) [ Time Frame: At week 36 and week 64 ]
8.	Change from baseline in CST at Weeks 36 and 64 [ Time Frame: At baseline, week 36 and week 64 ]
9.	Change from baseline in NEI VFQ 25 total score at Weeks 36 and 64 [ Time Frame: At baseline, week 36 and week 64 ]
10.	Number of participant with TEAEs and SAEs through Weeks 36 and 64 [ Time Frame: Through weeks 36 and 64 ]
11.	Participants dosed only Q8W through Week 36 in the 8 mg Q8W group [ Time Frame: Through weeks 36 ]
12.	Participants having last treatment intervals ≥12 or of 16 weeks at Week 64 [ Time Frame: At week 64 ]
13.	Participants having next intended interval ≥12 or of 16 weeks at Week 64 [ Time Frame: At week 64 ]
14.	Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Weeks 36 and 64 [ Time Frame: From baseline through weeks 36 and 64 ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Adult ≥18 years of age (or country's legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent. Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye. Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye. Decrease in BCVA determined to be primarily the result of RVO in the study eye. Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch's membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch's membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye. Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws. Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2. Exclusion Criteria: Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye. Presence or history of the following ocular conditions: Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye. Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye. Macular hole of stage 2 and above in the study eye. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye. Corneal transplant or corneal dystrophy in the study eye. Idiopathic or autoimmune uveitis in the study or in the fellow eye. Presence of the following ocular conditions at screening or baseline visit: Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography [FP], OCT) in the study eye. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye. Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye. Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye. Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye. Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg) at the screening visit or baseline visit. Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) >12% at the screening visit. History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits. Renal failure requiring dialysis, or renal transplant at screening or potentially during the study. Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye. Previous administration of systemic anti-angiogenic medications for any condition. Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures: Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies). Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time. Treatment with ocriplasmin at any time. Vitreoretinal surgery (including scleral buckling) at any time. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit. Previous treatment with retinal laser photocoagulation. Prior treatment of the fellow eye with any of the following: a. Gene therapy, or cell therapy in the fellow eye at any time. Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.

Contacts/Locations


Central Contact Person:	Bayer Clinical Trials Contact Telephone: (+)1-888-84 22937 Email: clinical-trials-contact@bayer.com
Locations:	United States, California
	Retina Consultants of Orange County Fullerton, California, United States, 92835
	Mountain View \| Ophthalmology Loma Linda, California, United States, 92354
	South Coast Retina Center Long Beach, California, United States, 90807
	Northern California Retina-Vitreous Associates Mountain View, California, United States, 94040
	Southern California Desert Retina Consultants Palm Springs, California, United States, 92262
	California Eye Specialists Pasadena, California, United States, 91107
	Southern California Permanente Medical Group Riverside, California, United States, 92505
	Stanford University Stanford, California, United States, 94305
	United States, Colorado
	Retina Consultants of Southern Colorado, PC Colorado Springs, Colorado, United States, 80909
	United States, Connecticut
	New England Retina Associates New London, Connecticut, United States, 06320
	United States, Florida
	Rand Eye Institute Deerfield Beach, Florida, United States, 33064
	National Ophthalmic Research Institute Fort Myers, Florida, United States, 33912
	Eye Institute of West Florida Largo, Florida, United States, 33770
	Florida Eye Associates Melbourne, Florida, United States, 32901
	Florida Retina Institute Orlando, Florida, United States, 32806
	Retina Specialists Pensacola, Florida, United States, 32503
	Fort Lauderdale Eye Institute Plantation, Florida, United States, 33324
	Retina Vitreous Associates of Florida - Saint Petersburg Saint Petersburg, Florida, United States, 33711-1141
	East Florida Eye Institute Stuart, Florida, United States, 34994
	University of South Florida Tampa, Florida, United States, 33612
	Center for Retina and Macular Disease Winter Haven, Florida, United States, 33880
	United States, Georgia
	Marietta Eye Clinic Marietta, Georgia, United States, 30060
	United States, Illinois
	Retina Associates IL Elmhurst, Illinois, United States, 60126
	University Retina and Macula Associates Oak Forest, Illinois, United States, 60452
	United States, Kansas
	Retina Associates, LLC Lenexa, Kansas, United States, 66215
	United States, Maryland
	Retina Care Center Baltimore, Maryland, United States, 21209
	Cumberland Valley Retina Consultants, PC Hagerstown, Maryland, United States, 21740
	Mid Atlantic Retina Specialists Hagerstown, Maryland, United States, 21740
	United States, Michigan
	Vitreo-Retinal Associates, PC Grand Rapids, Michigan, United States, 49525
	United States, Minnesota
	Retina Consultants of Minnesota Saint Louis Park, Minnesota, United States, 55416
	United States, Nevada
	Retina Consultants of Nevada Las Vegas, Nevada, United States, 89144
	Sierra Eye Associates Reno, Nevada, United States, 89502
	United States, New Jersey
	Retina Center of New Jersey Bloomfield, New Jersey, United States, 07003
	NJ Retina New Brunswick, New Jersey, United States, 08901
	NJ Retina \| Teaneck Teaneck, New Jersey, United States, 07666
	United States, New Mexico
	Eye Associates of New Mexico Albuquerque, New Mexico, United States, 87106
	United States, New York
	Long Island Vitreoretinal Consultants Great Neck, New York, United States, 11021
	Long Island Vitreoretinal Consultants Hauppauge, New York, United States, 11788
	Ophthalmic Consultants of Long Island Lynbrook, New York, United States, 11563
	Retina Associates of Western New York Rochester, New York, United States, 14620
	Ophthalmic Consultants of the Capital Region Troy, New York, United States, 12180
	United States, North Carolina
	University of NC at Chapel Hill (UNC) Ophthalmology Chapel Hill, North Carolina, United States, 27599
	Wake Forest Baptist Health Winston-Salem, North Carolina, United States, 27157
	United States, Ohio
	Cincinnati Eye Institute Cincinnati, Ohio, United States, 45242
	Midwest Retina - Main Office Dublin, Ohio, United States, 43016
	United States, Oregon
	Retina Consultants, LLC Salem, Oregon, United States, 97302
	United States, Pennsylvania
	University of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
	Mid Atlantic Retina Philadelphia, Pennsylvania, United States, 19107
	United States, South Carolina
	Retina Consultants of Charleston Charleston, South Carolina, United States, 29414
	Palmetto Retina Center, LLC - Florence Florence, South Carolina, United States, 29501
	Palmetto Retina Center, LLC West Columbia, South Carolina, United States, 29169
	United States, Tennessee
	Charles Retina Institute Memphis, Tennessee, United States, 38119
	United States, Texas
	Austin Retina Associates Austin, Texas, United States, 78705
	Retinal Consultants of Texas - Bellaire Bellaire, Texas, United States, 77401
	Texas Retina Associates Fort Worth, Texas, United States, 76104
	Medical Center Ophthalmology Associates San Antonio, Texas, United States, 78240
	Retinal Consultants of Texas - San Antonio San Antonio, Texas, United States, 78240
	United States, Utah
	Rocky Mountain Retina Consultant Salt Lake City, Utah, United States, 84107
	United States, Virginia
	The Retina Group of Washington \| Fairfax Virginia Beach, Virginia, United States, 22031
	United States, Washington
	Spokane Eye Clinical Research Spokane, Washington, United States, 99204
	United States, Wisconsin
	University of Wisconsin - Madison Madison, Wisconsin, United States, 53792
	Australia, New South Wales
	Eyeclinic Albury Wodonga Albury, New South Wales, Australia, 2640
	Marsden Eye Surgery Center Parramatta, New South Wales, Australia, 2150
	Strathfield Retina Clinic Strathfield, New South Wales, Australia, 2135
	Sydney Eye Hospital Sydney, New South Wales, Australia, 2000
	Sydney Retina Clinic Sydney, New South Wales, Australia, 2000
	Sydney West Retina Pty Ltd Westmead, New South Wales, Australia, 2145
	Australia, South Australia
	Adelaide Eye and Retina Centre Adelaide, South Australia, Australia, 5000
	Australia, Tasmania
	Hobart Eye Surgeons Hobart, Tasmania, Australia, 7000
	Australia, Victoria
	Centre for Eye Research East Melbourne, Victoria, Australia, 3002
	Australia, Western Australia
	Lions Eye Institute Nedlands, Western Australia, Australia, 6009
	Austria
	Kepler Universitätsklinikum Campus III Linz, Austria, 4021
	Universitätsklinikum AKH Wien Wien, Austria, 1090
	Hanusch-Krankenhaus Wien Wien, Austria, 1140
	Austria, Kärnten
	Klinikum Klagenfurt am Wörthersee Klagenfurt, Kärnten, Austria, 9020
	Austria, Oberösterreich
	Konventhospital Barmherzige Brüder Linz Linz, Oberösterreich, Austria, 4021
	Austria, Steiermark
	Medizinische Universität Graz Graz, Steiermark, Austria, 8036
	Bulgaria
	SEHAT Pentagram Sofia, Bulgaria, 1309
	UMHAT Alexandrovska EAD Sofia, Bulgaria, 1431
	Multiprofile Hospital for Active Treatment Sveta Sofia Sofia, Bulgaria, 1618
	Specialized Hospital For Active Treatment of Eye Diseases Zora Sofia, Bulgaria, 1784
	Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna Varna, Bulgaria, 9000
	China
	Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology Beijing, China, 100021
	China-Japan Friendship Hospital Beijing, China, 100029
	Beijing Hospital Beijing, China, 100730
	Capital Medical University (CMU) - Beijing Tongren Hospital Beijing, China, 100730
	Peking Union Medical College Hospital CAMS Beijing, China, 100730
	Peking University First Hospital Beijing, China
	Chongqing Aier Ophthalmology Hospital Chongqing, China, 400000
	The First Affiliated Hospital of Chongqing Medical Universit Chongqing, China, 401147
	Second Hospital Affiliated of Chongqing Medical University Chongqing, China
	Zhejiang University School of Medicine - The First Affiliated Hospital - Kidney Disease Center Hangzhou, China, 310003
	Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University) Lanzhou, China, 730030
	Eye & Ent Hospital of Fudan University Shanghai, China
	China Medical University (CMU) - First Affiliated Hospital Shenyang, China, 110001
	Tianjin Medical University General Hospital Tianjin, China, 300052
	Tianjin Medical University Eye Hospital Tianjin, China, 300384
	TianJin eye hospital Tianjin, China
	China, Anhui
	The Second Hospital of Anhui medical university Hefei, Anhui, China, 230601
	China, Guangdong
	Guangzhou Aier Eye Hospital Guangzhou, Guangdong, China, 634050
	China, Hebei
	Shijiazhuang General Hospital Shijiazhuang, Hebei, China, 050000
	Hebei Eye Hospital Xingtai, Hebei, China
	China, Henan
	Henan Provincial Ophthalmology Hospital (Henan Eye Institute Zhengzhou, Henan, China, 450003
	China, Hubei
	Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. Wuhan, Hubei, China, 430030
	Renmin Hospital of Wuhan University Wuhan, Hubei, China, 430040
	China, Jiangsu
	The First People's Hospital of Xuzhou Xuzhou, Jiangsu, China, 221002
	China, Jilin
	Eye Center of the second Bethune Hospital, jinlin University Changchun, Jilin, China, 130022
	China, Liaoning
	Shenyang Fourth People's Hospital - Ophthalmology Shenyang, Liaoning, China, 110031
	Aier Eye Hospital(SHENYANG) Shenyang, Liaoning, China
	China, Ningxia
	The People's Hospital of Ningxia Hui Autonomous Region Yinchuan, Ningxia, China, 750000
	China, Shaanxi
	Shanxi Provincial Eye Hospital Taiyuan, Shaanxi, China, 030072
	The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, Shaanxi, China, 710061
	China, Shandong
	Qilu Hospital of Shandong University Jinan, Shandong, China, 250012
	China, Sichuan
	West China Hospital,Sichuan University Chengdu, Sichuan, China, 610041
	Aier Eye Hospital (Chengdu) Chengdu, Sichuan, China
	China, Zhejiang
	ZheJiang Provincial People's Hospital Hangzhou, Zhejiang, China, 310014
	Dongyang People's Hospital Jinhua, Zhejiang, China, 322199
	The Affiliated Eye Hospital of Wenzhou Medical College Wenzhou, Zhejiang, China
	Czechia
	Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czechia, 500 05
	Fakultni nemocnice Ostrava Ostrava, Czechia, 708 52
	Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice Pardubice, Czechia, 53003
	FN Kralovske Vinohrady Praha 10, Czechia, 10034
	Vseobecna fakultni nemocnice v Praze Praha 2, Czechia, 12800
	Lexum a.s., Evropska ocni klinika Praha 4, Czechia, 140 00
	AXON Clinical s.r.o. Praha 5, Czechia, 150 00
	Estonia
	East Tallinn Central Hospital Tallinn, Estonia, 10138
	Turman Eye Clinic Tallinn, Estonia, 11314
	Dr. Kai Noor Silmakabinet OU Tallinn, Estonia, 11412
	Tartu University Hospital Tartu, Estonia
	France
	Clinique Rétine Tourny Bordeaux, France, 33000
	CHU Bordeaux - Hopital Pellegrin - Ophtalmologie Bordeaux, France, 33076
	Hôpital Intercommunal - Créteil Cedex Creteil Cedex, France, 94010
	Hôpital François Mitterrand - Dijon Dijon, France, 21000
	Hôpital de la Croix Rousse Lyon Cedex 04, France, 69317
	Centre d'Ophtalmologie - Paradis-Monticelli Marseille, France, 13008
	Clinique Jules Verne - Nantes Nantes, France, 44000
	Centre d'ophtalmologie de l'Odéon Paris, France, 75006
	Hôpital Lariboisière - Paris Paris, France, 75010
	Centre Ophthalmologie d'Imagerie et de Laser Paris, France, 75015
	CM Wolff Strasbourg, France, 67000
	Centre Ophtalmologique Transparence - Tours Tours, France, 37000
	France, Cedex 12
	Centre Hospitalier National d'Ophthalmologie Quinze-Vingt Paris, Cedex 12, France, 75557
	Georgia
	LTD "IQ Clinic" Tbilisi, Georgia, 105
	LTD Israeli-Georgian Medical Research Clinic "Helsicore" Tbilisi, Georgia, 112
	LTD "Chichua Medical Center MZERA" Tbilisi, Georgia, 114
	Caucasus Medical Center- Opthamology Tbilisi, Georgia
	Hungary
	Jahn Ferenc Del-Pesti Korhaz es Rendelointezet Budapest, Hungary, 1024
	MH Egeszsegugyi Kozpont Budapest, Hungary, 1062
	University of Semmelweis/ Semmelweis Egyetem Budapest, Hungary, 1085
	Bajcsy Zsilinszky Korhaz-Rendelointezet Budapest, Hungary, 1106
	Budapest Retina Associates Budapest, Hungary, 1133
	Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032
	Ganglion Medical Center Pecs, Hungary, 7621
	SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6720
	Israel
	Soroka University Medical Center Beer Sheva, Israel, 8410101
	Rambam Health Corporation Haifa, Israel, 3109601
	Lady Davis Carmel Medical Center Haifa, Israel, 3436212
	Edith Wolfson Medical Center Holon, Israel, 5822012
	Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 91120
	Meir Medical Center Kfar Saba, Israel, 4428164
	Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492
	Kaplan Medical Center Rehovot, Israel, 7661041
	Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906
	Assuta Medical Centers - HaShalom Tel Aviv, Israel, 6789140
	Shamir Medical Center (Assaf Harofeh) Zerifin, Israel, 7030000
	Italy
	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122
	Italy, Lazio
	Fondazione PTV Policlinico Tor Vergata Roma, Lazio, Italy, 00133
	Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Lazio, Italy, 00168
	IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia Roma, Lazio, Italy, 00198
	Italy, Lombardia
	Ospedale San Raffaele s.r.l. Milano, Lombardia, Italy, 20132
	ASST Fatebenefratelli Sacco Milano, Lombardia, Italy, 20157
	Italy, Marche
	A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" Ancona, Marche, Italy, 60126
	Italy, Piemonte
	A.O. Ordine Mauriziano Torino, Piemonte, Italy, 10128
	Italy, Puglia
	A.O.U. Consorziale Policlinico Bari, Puglia, Italy, 70124
	Japan
	Akita University Hospital Akita, Japan, 010-8543
	Hayashi Eye Hospital Fukuoka, Japan, 812-0011
	Murakami Karindoh Hospital Fukuoka, Japan, 819-8585
	Fukushima Medical University Hospital Fukushima, Japan, 960-1295
	Kagoshima University Hospital Kagoshima, Japan, 890-8520
	University of Miyazaki Hospital Miyazaki, Japan, 889-1692
	Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki, Japan, 852-8511
	Osaka Metropolitan University Hospital Osaka, Japan, 545-8586
	Japanese Red Cross Saitama Hospital Saitama, Japan, 330-8553
	Japanese Red Cross Wakayama Medical center Wakayama, Japan, 640-8558
	Yamagata University Hospital Yamagata, Japan, 990-9585
	Japan, Aichi
	Nagoya City University Hospital Nagoya, Aichi, Japan, 467-8602
	Japan, Chiba
	International University of Health & Welfare Narita Hospital Narita, Chiba, Japan, 286-8520
	Toho University Sakura Medical Center Sakura, Chiba, Japan, 285-8741
	Japan, Fukui
	University of Fukui Hospital Yoshida, Fukui, Japan, 910-1193
	Japan, Fukuoka
	Kurume University Hospital Kurume, Fukuoka, Japan, 830-0011
	Japan, Fukushima
	Southern Tohoku Eye Clinic Koriyama, Fukushima, Japan, 963-8052
	Japan, Gunma
	Gunma University Hospital Maebashi, Gunma, Japan, 371-8511
	Japan, Hyogo
	Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Hyogo, Japan, 660-8550
	Kobe University Hospital Kobe, Hyogo, Japan, 650-0017
	Hyogo Medical University Hospital Nishinomiya, Hyogo, Japan, 663-8501
	Japan, Ibaraki
	Kozawa Eye Hospital and Diabetes Center Mito, Ibaraki, Japan, 310-0845
	Medical corporation Jiseikai Matsumoto Eye Clinic Toride, Ibaraki, Japan, 302-0014
	Japan, Kagawa
	Kagawa University Hospital Kita-gun, Kagawa, Japan, 761-0793
	Japan, Kanagawa
	Medical corporation Eiwakai Dannoue Ophthalmology clinic Kawasaki, Kanagawa, Japan, 211-0053
	Yokohama City University Medical Center Yokohama, Kanagawa, Japan, 232-0024
	Japan, Mie
	Mie University Hospital Tsu, Mie, Japan, 514-8507
	Japan, Nagano
	Shinshu University Hospital Matsumoto, Nagano, Japan, 390-8621
	Japan, Saitama
	National Defense Medical College Hospital Tokorozawa, Saitama, Japan, 359-8513
	Japan, Shiga
	Shiga University of Medical Science Hospital Otsu, Shiga, Japan, 520-2192
	Japan, Shizuoka
	Shida Eye Clinic Fujieda, Shizuoka, Japan, 426-0029
	Japan, Tokyo
	The University of Tokyo Hospital Bunkyo-ku, Tokyo, Japan, 113-8655
	Nihon University Hospital Chiyoda-ku, Tokyo, Japan, 101-8309
	Medical corporation Chofu Eye Clinic Chofu, Tokyo, Japan, 182-0024
	Tokyo Medical University Hachioji Medical Center Hachioji, Tokyo, Japan, 193-0998
	Tokyo Metropolitan Institute for Geriatrics and Gerontology Itabashi-ku, Tokyo, Japan, 173-0015
	Tokiwadai Muranaka Eye Clinic Itabashi-ku, Tokyo, Japan, 174-0071
	National Hospital Organization Tokyo Medical Center Meguro-ku, Tokyo, Japan, 152-8902
	Keio University Hospital Shinjuku-ku, Tokyo, Japan, 160-8582
	Tokyo Women's Medical University Hospital Shinjuku-ku, Tokyo, Japan, 162-8666
	Japan, Yamaguchi
	Yamaguchi University Hospital Ube, Yamaguchi, Japan, 755-8505
	Japan, Yamanashi
	University of Yamanashi Hospital Chuo, Yamanashi, Japan, 409-3898
	Korea, Republic of
	Pusan National University Hospital Busan, Korea, Republic of, 49241
	Yeungnam University Medical Center Daegu, Korea, Republic of, 42415
	Korea University Ansan Hospital Gyeonggi-do, Korea, Republic of, 425-707
	Severance Hospital, Yonsei University Health System Seoul, Korea, Republic of, 03722
	Asan Medical Center Seoul, Korea, Republic of, 05505
	Seoul National University Hospital Seoul, Korea, Republic of, 110-744
	Samsung Medical Center Seoul, Korea, Republic of, 135-710
	Kim's Eye Hospital Seoul, Korea, Republic of, 150-034
	St. Mary Hospital Seoul, Korea, Republic of, 150-713
	Korea, Republic of, Gyeonggido
	Seoul National University Bundang Hospital Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
	Korea, Republic of, Seoul Teugbyeolsi
	Gangnam Severance Hospital, Yonsei University Health System Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
	Latvia
	Department of Ophthalmology Riga, Latvia, 1002
	Riga East Clinical University Hospital "Gailezers" Riga, Latvia, LV-1006
	Latvian American Eye Center Riga, Latvia, LV-1009
	Lithuania
	Hospital of LT University of Health Sciences Kaunas Clinics Kaunas, Lithuania, LT-50161
	Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661
	Malaysia
	Hospital Al-Sultan Abdullah, UiTM \| Opthalmology Bandar Puncak Alam, Malaysia, 42300
	OasisEye Specialists Kuala Lumpur, Malaysia, 59200
	Hospital Shah Alam \| Ophthalmology Shah Alam, Malaysia, 40000
	Hospital Selayang Shah Alam, Malaysia, 68100
	Mexico
	Santa Lucia Clinica \| Oftalmologica Guadalajara, Mexico, 44670
	FAP Conde de Valenciana, IAP \| Oftalmología Mexico City, Mexico, 06800
	Hospital Angeles Mocel \| Oftalmologia Mexico City, Mexico, 11850
	Instituto Mexicano de Oftalmologia, IMO Queretaro, Mexico, 76090
	Instituto de la Retina del Bajío SC Queretaro, Mexico, 76187
	Mexico, Distrito Federal
	Fundacion Hospital Nuestra Señora de la Luz Mexico D. F., Distrito Federal, Mexico, 06030
	Poland
	Prywatna Klinika Okulistyczna OFTALMIKA Bydgoszcz, Poland, 85-631
	Specjalistyczny Osrodek Okulistyczny Oculomedica Bydgoszcz, Poland, 85-870
	NZOZ Poradnia Okulistyczna Dobry Wzrok Gdansk, Poland, 80-402
	Profesorskie Centrum Okulistyki Gdansk, Poland, 80-809
	Gabinet Okulistyczny Prof. Edward Wylegala Katowice, Poland, 40-594
	Centrum Medyczne Dietla 19 Sp. z o.o. Krakow, Poland, 31-070
	Centrum Medyczne PROMED Krakow, Poland, 31-411
	Centrum Diagnostyki i Mikrochirurgii Oka Lens Olsztyn, Poland, 10-424
	Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o. Rzeszow, Poland, 35-017
	Centrum Medyczne Piasta Walbrzych, Poland, 58-304
	Portugal
	AIBILI Coimbra, Portugal, 3000-548
	Espaco Medico de Coimbra Coimbra, Portugal, 3000-548
	CHLC - Hospital dos Capuchos - Servico de Oftalmologia Lisboa, Portugal, 1169-050
	Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001
	CHUSJ - Hospital Sao Joao Porto, Portugal, 4200-319
	Portugal, Porto
	Centro Hospitalar Vila Nova de Gaia/Espinho \| Unit 1 - Clinical Research Office Vila Nova de Gaia, Porto, Portugal, 4434-502
	Serbia
	Clinical Center of Serbia Belgrade, Serbia, 11000
	Clinical hospital center Zvezdara Belgrade, Serbia, 11000
	Klinicki centar Vojvodine Novi Sad, Serbia, 21000
	Slovakia
	Fakultna Nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica, Slovakia, 97517
	Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Bratislava, Slovakia, 82606
	Univerzitna nemocnica Bratislava, Petrzalka Bratislava, Slovakia, 851 07
	Fakultna nemocnica Nitra Nitra, Slovakia, 95001
	Nemocnica Poprad, a.s. Poprad, Slovakia, 058 45
	Fakultna nemocnica Trencin Trencin, Slovakia, 911 71
	Specialized hospital for ophthalmology OPHTAL Zvolen, Slovakia, 960 01
	Spain
	Hospital Vall d'Hebron - Servei d'Oftalmologia Barcelona, Spain, 08035
	Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 8036
	Hospital de la Santa Creu i Sant Pau \| Gynecology Department Barcelona, Spain, 8041
	Hospital Reina Sofía Córdoba, Spain, 14004
	Clínica Universidad de Navarra CUN Pamplona, Spain, 31008
	Hospital General Universitario de Valencia Valencia, Spain, 46014
	Hospital del Rio Hortega Valladolid, Spain, 47012
	Hospital Miguel Servet Zaragoza, Spain, 50009
	Spain, A Coruña
	Instituto Oftalmológico Francisco Gomez Ulla Santiago de Compostela, A Coruña, Spain, 15706
	Spain, Barcelona
	Hospital General de Catalunya Sant Cugat del Vallés, Barcelona, Spain, 08195
	Spain, Madrid
	Hospital Universitario Clinica Puerta de Hierro Majadahonda, Madrid, Spain, 28222
	Switzerland
	Inselspital Universitätsspital Bern Bern, Switzerland, 3010
	Berner Augenklinik am Lindenhofspital Bern, Switzerland
	Vista Klinik Binningen, Switzerland, 4102
	University Eye Hospital Jules Gonin Lausanne, Switzerland, 1004
	Switzerland, Vaud
	RétinElysée Lausanne, Vaud, Switzerland, 1006
	Thailand
	Srinagarind Hospital Khon Kaen, Thailand, 40002
	Turkey
	Cukurova Universitesi Tip Fakultesi Hastanesi Adana, Turkey, 01330
	SBU Gulhane Egitim ve Arastirma Hastanesi Ankara, Turkey, 06010
	Ankara Numune Egitim ve Arastirma Hastanesi Ankara, Turkey, 06100
	Ankara Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 06100
	Hacettepe Universitesi Tip Fakultesi Ankara, Turkey, 06100
	Baskent Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 06490
	Gazi Universitesi Tip Fakultesi Ankara, Turkey, 06500
	Ankara Bilkent Sehir Hastanesi Ankara, Turkey, 06800
	Adnan Menderes Universitesi Tip fakultesi Aydin, Turkey, 09100
	Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093
	Beyoglu Eye Training and Research Hospital Istanbul, Turkey, 34420
	Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100
	Kocaeli Universitesi Tip Fakultesi Kocaeli, Turkey, 41380
	United Kingdom
	Bradford Royal Infirmary Bradford, United Kingdom, BD9 6RJ
	Royal Liverpool University Hospital Liverpool, United Kingdom, L7 8XP
	Moorfields Eye Hospital London, United Kingdom, EC1V 2PD
	United Kingdom, Essex
	Colchester General Hospital Colchester, Essex, United Kingdom, CO4 5JR
	United Kingdom, Hertfordshire
	Barnet General Hospital Barnet, Hertfordshire, United Kingdom, EN5 3DJ
	United Kingdom, Leicestershire
	Leicester Royal Infirmary Leicester, Leicestershire, United Kingdom, LE1 5WW
	United Kingdom, Norfolk
	James Paget Hospital Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
	United Kingdom, Surrey
	Frimley Park Hospital NHS Camberley, Surrey, United Kingdom, GU16 7UJ
	Epsom General Hospital Epsom, Surrey, United Kingdom, KT18 7EG
	United Kingdom, Tyne And Wear
	Sunderland Eye Infirmary Sunderland, Tyne And Wear, United Kingdom, SR2 9HP
	United Kingdom, West Midlands
	University Hospitals Coventry and Warwickshire NHS Trust Coventry, West Midlands, United Kingdom, CV2 2DX
	New Cross Hospital Wolverhampton, West Midlands, United Kingdom, WV10 0QP
	United Kingdom, West Yorkshire
	St James' University Hospital Leeds, West Yorkshire, United Kingdom, LS9 7TF
	United Kingdom, York
	Hull and East Yorkshire Eye Hospital Hull and East Yorkshire Hull, York, United Kingdom, HU3 2JZ

IPDSharing

Plan to Share IPD:

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

References


Citations:
Links:	URL: https://clinicaltrials.bayer.com/ Description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Available IPD/Information: