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Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02286089
Recruitment Status : Active, not recruiting
First Posted : November 7, 2014
Results First Posted : March 6, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Intervention Biological: OpRegen
Enrollment 24
Recruitment Details  
Pre-assignment Details The enrollment into the study was staggered with 4 week intervals between the first 3 cohorts to allow for data safety monitory board (DSMB) review. Accumulated data of participants was reviewed by the DSMB before continuation to Cohort 4. All four cohorts were then followed in parallel.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0. Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0. Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0. Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Period Title: Overall Study
Started 3 3 6 12
Completed 2 2 0 0
Not Completed 1 1 6 12
Reason Not Completed
Ongoing in Study             1             1             4             10
Withdrawal by Subject             0             0             2             2
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Total
Hide Arm/Group Description Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0. Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0. Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0. Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants 12 participants 24 participants
77.4  (2.7) 74.4  (8.7) 80.4  (9.9) 78.1  (8.2) 76.9  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 12 participants 24 participants
Female
2
  66.7%
3
 100.0%
2
  33.3%
6
  50.0%
13
  54.2%
Male
1
  33.3%
0
   0.0%
4
  66.7%
6
  50.0%
11
  45.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 12 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
 100.0%
3
 100.0%
6
 100.0%
12
 100.0%
24
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
6
 100.0%
12
 100.0%
24
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. The AE's were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0.
Time Frame From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received OpRegen in the study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.
Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Number of Participants Analyzed 3 3 6 12
Measure Type: Number
Unit of Measure: percentage of participants
Blood and lymphatic system disorders 33.3 33.3 0 8.3
Cardiac disorders 33.3 0 0 8.3
Ear and labyrinth disorders 66.7 33.3 16.7 8.3
Endocrine disorders 0 0 0 8.3
Eye disorders 100 100 100 100
Gastrointestinal disorders 66.7 66.7 0 33.3
General disorders and administration site conditions 66.7 100 50.0 16.7
Infections and infestations 100 66.7 50.0 33.3
Injury, poisoning and procedural complications 66.7 100 50.0 16.7
Investigations 100 66.7 33.3 75.0
Metabolism and nutrition disorders 0 0 16.7 33.3
Musculoskeletal and connective tissue disorders 66.7 66.7 0 33.3
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 0 33.3 50.0 25.0
Nervous system disorders 0 33.3 50.0 33.3
Psychiatric disorders 0 0 0 8.3
Surgical and medical procedures 100 66.7 0 16.7
Skin and subcutaneous tissue disorders 33.3 33.3 33.3 8.3
Vascular disorders 0 0 16.7 16.7
Product issues 66.7 0 0 0
Renal and urinary disorders 0 0 33.3 0
Respiratory, thoracic and mediastinal disorders 66.7 66.7 16.7 0
2.Primary Outcome
Title Change From Baseline in Intraocular Pressure (IOP)
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received OpRegen in the study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.
Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Number of Participants Analyzed 3 3 6 12
Mean (Standard Error)
Unit of Measure: mmHg
Baseline Number Analyzed 3 participants 3 participants 6 participants 12 participants
13.3  (2.3) 14.0  (0.0) 13.7  (3.7) 14.6  (3.1)
Change from Baseline at Month 12 Number Analyzed 3 participants 3 participants 5 participants 12 participants
1.0  (2.6) 1.0  (1.7) -0.4  (2.5) -0.6  (1.4)
3.Secondary Outcome
Title Change From Baseline in Geographic Atrophy (GA) Lesion Area
Hide Description The GA lesion area was based on available Fundus Autofluorescence (FAF) imaging data by a central reading center.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population included all participants who received OpRegen in the study and for whom imaging data were available.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.
Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Number of Participants Analyzed 3 3 6 12
Mean (Standard Deviation)
Unit of Measure: mm^2
Baseline Number Analyzed 3 participants 3 participants 6 participants 12 participants
13.5  (6.4) 18.5  (10.6) 9.4  (2.0) 7.4  (2.9)
Change from Baseline at Month 12 Number Analyzed 2 participants 1 participants 3 participants 11 participants
2.3  (1.9) 1.6 [1]   (NA) 2.5  (4.0) 1.8  (0.8)
[1]
NA: Standard deviation cannot be calculated for 1 participant.
4.Secondary Outcome
Title Change From Baseline in Visual Acuity
Hide Description Change from baseline in visual acuity was measured by retro illuminated ETDRS chart from 4 meters distance. Visual acuity was reported as the number of letters read correctly.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population included all participants who received OpRegen in the study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.
Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Number of Participants Analyzed 3 3 6 12
Mean (Standard Deviation)
Unit of Measure: number of letters
Baseline Number Analyzed 3 participants 3 participants 6 participants 12 participants
20.0  (18.0) 14.3  (7.2) 29.8  (6.8) 44.8  (7.5)
Change from Baseline at Month 12 Number Analyzed 3 participants 3 participants 5 participants 12 participants
15.7  (34.2) 3.0  (8.7) -1.4  (17.8) 7.6  (8.7)
5.Secondary Outcome
Title Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Quality of Life
Hide Description The NEI VFQ-25 is a 25 item patient-reported questionnaire. The composite score ranges from 0-100 with the higher score indicating better visual function.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population included all participants who received OpRegen in the study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description:
Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.
Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.
Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Number of Participants Analyzed 3 3 6 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 3 participants 3 participants 6 participants 12 participants
50.3  (15.3) 42.9  (6.0) 46.9  (18.8) 62.2  (13.8)
Change from Baseline at Month 12 Number Analyzed 3 participants 3 participants 5 participants 11 participants
5.1  (10.8) -5.7  (17.6) 3.1  (18.2) 3.7  (11.4)
Time Frame From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years)
Adverse Event Reporting Description Safety Population included all participants who received OpRegen in the study.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0. Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0. Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0. Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Cohort 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Cohort 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      2/3 (66.67%)      2/6 (33.33%)      4/12 (33.33%)    
Cardiac disorders         
Atrial fibrillation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Endocrine disorders         
Hypercalcaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Eye disorders         
Retinal detachment * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
Macular fibrosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
General disorders         
Chest pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations         
Respiratory tract infection * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Cellulitis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Pneumonia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications         
Radius fracture * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Investigations         
Electrocardiogram change * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
B-cell lymphoma * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Lung adenocarcinoma stage IV * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Lung neoplasm * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Malignant melanoma * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders         
Syncope * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders         
Pulmonary congestion * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Vascular disorders         
Arterial thrombosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, MedDRA version 25.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2 Cohort 3 Cohort 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders         
Haemorrhagic disorder * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Leukopenia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Lymphocytopenia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Cardiac disorders         
Atrial fibrillation * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Cardiac failure congestive * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Ear and labyrinth disorders         
Conductive deafness * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Deafness * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
Hypoacusis * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Vertigo * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0
Eye disorders         
Cataract * 1  1/3 (33.33%)  1 2/3 (66.67%)  2 4/6 (66.67%)  6 1/12 (8.33%)  1
Macular fibrosis * 1  2/3 (66.67%)  2 3/3 (100.00%)  6 5/6 (83.33%)  7 6/12 (50.00%)  9
Subretinal fluid * 1  2/3 (66.67%)  6 2/3 (66.67%)  2 1/6 (16.67%)  2 2/12 (16.67%)  3
Age-related macular degeneration * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Anterior chamber disorder * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Blepharitis * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Cataract nuclear * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Conjunctival haemorrhage * 1  1/3 (33.33%)  1 3/3 (100.00%)  3 3/6 (50.00%)  3 8/12 (66.67%)  9
Conjunctival hyperaemia * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Conjunctival irritation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Conjunctival oedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Dry eye * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
Eye irritation * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/12 (16.67%)  2
Eye pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 1/12 (8.33%)  1
Eyelid haematoma * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Eyelid oedema * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Eyelid ptosis * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/12 (16.67%)  2
Foreign body sensation in eyes * 1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0
Glaucoma * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Hyphaema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Lacrimation increased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Macular hole * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  1 0/12 (0.00%)  0
Macular oedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Ocular hyperaemia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Optic atrophy * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Papilloedema * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Photopsia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Posterior capsule opacification * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Punctate keratitis * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Retinal cyst * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Retinal depigmentation * 1  2/3 (66.67%)  2 2/3 (66.67%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0
Retinal haemorrhage * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 5/12 (41.67%)  5
Retinal pigmentation * 1  2/3 (66.67%)  3 3/3 (100.00%)  5 2/6 (33.33%)  6 2/12 (16.67%)  2
Retinal tear * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
Retinopathy proliferative * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 0/12 (0.00%)  0
Retinoschisis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 2/12 (16.67%)  2
Vision blurred * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Visual acuity reduced * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3 0/12 (0.00%)  0
Visual impairment * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Vitreous floaters * 1  0/3 (0.00%)  0 2/3 (66.67%)  2 1/6 (16.67%)  1 0/12 (0.00%)  0
Blebitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Choroidal neovascularisation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/12 (25.00%)  3
Conjunctival bleb * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/12 (8.33%)  1
Corneal disorder * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Corneal oedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2
Cystoid macular oedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Detachment of retinal pigment epithelium * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 5/12 (41.67%)  5
Eye pruritus * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2
Iritis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Photophobia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Pinguecula * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Vitreous detachment * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Vitreous haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Eye haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Retinal oedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2
Anterior Chamber inflammation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain lower * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Constipation * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/12 (8.33%)  1
Diarrhoea * 1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/6 (0.00%)  0 1/12 (8.33%)  1
Epigastric discomfort * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Nausea * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2
Vomiting * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Pouchitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Inguinal hernia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
General disorders         
Application site erythema * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Asthenia * 1  0/3 (0.00%)  0 3/3 (100.00%)  3 0/6 (0.00%)  0 0/12 (0.00%)  0
Fatigue * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/12 (16.67%)  2
Implant site atrophy * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Inflammation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Influenza like illness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Malaise * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0
Peripheral swelling * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations         
Conjunctivitis * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Cystitis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Nasopharyngitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 1/12 (8.33%)  2
Onychomycosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Otitis media * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Peptic ulcer helicobacter * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Pneumonia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Upper respiratory tract infection * 1  2/3 (66.67%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Urinary tract infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
Viral upper respiratory tract infection * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
COVID-19 * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Sinusitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Injury, poisoning and procedural complications         
Animal bite * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Animal scratch * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Ankle fracture * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Arthropod bite * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0
Cataract operation complication * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Contusion * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Eye contusion * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Fall * 1  0/3 (0.00%)  0 2/3 (66.67%)  3 0/6 (0.00%)  0 0/12 (0.00%)  0
Foot fracture * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Muscle contusion * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Ocular procedural complication * 1  1/3 (33.33%)  1 3/3 (100.00%)  3 1/6 (16.67%)  1 0/12 (0.00%)  0
Procedural nausea * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Post procedural inflammation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Wrist injury * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Investigations         
Activated partial thromboplastin time prolonged * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Alanine aminotransferase increased * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/12 (8.33%)  1
Angiogram abnormal * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Aspartate aminotransferase increased * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 0/12 (0.00%)  0
B-lymphocyte count abnormal * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Blood creatinine increased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Blood immunoglobulin G increased * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Blood phosphorus increased * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Blood pressure diastolic decreased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Blood uric acid increased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
C-reactive protein increased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
CD4/CD8 ratio decreased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Free prostate-specific antigen increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Red blood cell sedimentation rate increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
International normalised ratio increased * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Intraocular pressure increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 2/12 (16.67%)  3
Wound healing normal * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Gamma-glutamyltransferase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/12 (16.67%)  2
Blood calcium increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Blood creatine phosphokinase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2
Blood lactate dehydrogenase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Blood potassium increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2
Blood pressure increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Blood urea increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2
Cardiac murmur * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Creatinine renal clearance increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Immunosuppressant drug level increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
SGOT increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Intraocular pressure decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Serum ferritin decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Vital dye staining cornea present * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Vitamin B12 increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Metabolism and nutrition disorders         
Decreased appetite * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 3/12 (25.00%)  3
Glucose tolerance impaired * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Dehydration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/12 (8.33%)  1
Back pain * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 1/12 (8.33%)  1
Rotator cuff syndrome * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 1/12 (8.33%)  1
Intervertebral disc disorder * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Neck pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Muscle spasms * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1
Squamous cell carcinoma * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Prostate cancer * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders         
Dizziness * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 0/12 (0.00%)  0
Headache * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/12 (8.33%)  1
Presyncope * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Tunnel vision * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Carpal tunnel syndrome * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Depressed level of consciousness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Tremor * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2
Parkinson's disease * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Syncope * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Product Issues         
Device breakage * 1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Psychiatric disorders         
Nervousness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders         
Acute kidney injury * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Urinary tract discomfort * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchitis * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Dyspnoea * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Increased viscosity of upper respiratory secretion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Oropharyngeal pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Rash * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/12 (0.00%)  0
Skin lesion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  2 0/12 (0.00%)  0
Erythema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Night sweats * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Surgical and medical procedures         
Cataract operation * 1  2/3 (66.67%)  2 1/3 (33.33%)  2 0/6 (0.00%)  0 1/12 (8.33%)  1
Dental implantation * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Intra-ocular injection * 1  1/3 (33.33%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Knee arthroplasty * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0
Posterior lens capsulotomy * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0
Subconjunctival injection procedure * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
Vascular disorders         
Lymphoedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0
Hypertension * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, MedDRA version 25.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02286089    
Other Study ID Numbers: GR44172
First Submitted: November 2, 2014
First Posted: November 7, 2014
Results First Submitted: December 19, 2022
Results First Posted: March 6, 2023
Last Update Posted: April 17, 2024