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Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (DAVIO2)

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: NCT05381948
Recruitment Status : Active, not recruiting
First Posted : May 19, 2022
Last Update Posted : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
EyePoint Pharmaceuticals, Inc.

Brief Summary:
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Drug: Eyp-1901 Drug: Aflibercept 2Mg/0.05Ml Inj,Oph Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
Actual Study Start Date : July 28, 2022
Actual Primary Completion Date : November 7, 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EYP-1901 2060 ug
EYP-1901 2060 ug, single dose
Drug: Eyp-1901
Intravitreal Injection

Experimental: EYP-1901 3090 ug
EYP-1901 3090 ug, single dose
Drug: Eyp-1901
Intravitreal Injection

Active Comparator: Aflibercept
Aflibercept 2 mg [0.05mL] every 8 weeks
Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Intravitreal Injection
Other Name: Eylea




Primary Outcome Measures :
  1. Average change in best corrected visual acuity (BCVA) [ Time Frame: Week 28 and Week 32 ]

Secondary Outcome Measures :
  1. Change in best corrected visual acuity (BCVA) [ Time Frame: Baseline, Week 56 ]
  2. Mean change in central retinal thickness on optical coherence tomography (OCT) [ Time Frame: Baseline, Week 56 ]
  3. Number of rescue injections [ Time Frame: Week 56 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
  • Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
  • BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.

Exclusion Criteria:

  • Central subfield thickness (CST) > 350 µm in the study eye at the Screening Visit or Day 1.
  • Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma).
  • Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381948


Locations
Show Show 67 study locations
Sponsors and Collaborators
EyePoint Pharmaceuticals, Inc.
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Responsible Party: EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05381948    
Other Study ID Numbers: EYP-1901-201
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EyePoint Pharmaceuticals, Inc.:
wAMD
EYP-1901
EyePoint
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents