Phase 3 Study to Assess Efficacy, Safety & Tolerability of OCU410 For Geographic Atrophy Secondary to Dry AMD

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ocugen
Study ID
NCT07770828
Phase
PHASE3
Status
Recruiting
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Conditions

  • Dry Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OCU410 — BIOLOGICAL
    Subretinal Injection

Study Details

This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm

Key Dates

First listed
Aug 18, 2026
Start date
Aug 11, 2026
Status verified
Aug 2026
Primary completion
Jul 30, 2028
Completion
Jul 30, 2031

Study Design

Enrollment
237 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OCU410
    OCU410 Single Sub Retinal Injection, 200 µL, 1×10\^10 vg/eye
  • No Intervention: Untreated Control Arm
    Control Arm (Untreated)

Primary Outcome Measure

Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12 [ Time Frame: Month 12 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
associated Retina ConsultantsPhoenixArizona85381
Mallory Mintert
[email protected]
480-999-5458
Benjamin Bakall, MD (PRINCIPAL_INVESTIGATOR)
Erie Retina ResearchEriePennsylvania16505
Bethany Scott
[email protected]
814-737-0203
David Almeida, MD (PRINCIPAL_INVESTIGATOR)
Valley Retina InstituteMcAllenTexas78503
Alfred Halder
[email protected]
956-631-8875
Andres Rodriguez
[email protected]
956-631-8875
Victor H. Gonzalez (PRINCIPAL_INVESTIGATOR)

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associated Retina Consultants· Phoenix, AZErie Retina Research· Erie, PAValley Retina Institute· McAllen, TX

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