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RecruitingNCT07770828Updated Aug 19, 2026

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

A Phase 3 interventional study of OCU410 in Dry Age-related Macular Degeneration, sponsored by Ocugen. Recruiting at 3 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Ocugen · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
237
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 645 studies in Macular Degeneration with a site in United States — 85 open to participants now, 128 under way, 24 of them phase 3. Macular Degeneration · United States.

Planned enrollment
101st of 491
237 · median 55
Started
2026
with 27 others
Phase 3
86 of 645
8 open now
Primary completion
2028-07
later than 88 of 124 live
Registered
640th of 645
by date

Among the 645 studies in Macular Degeneration with a site in United States, this one is the 101st largest by planned enrollment of the 491 interventional ones that give a count, is one of 28 that started in 2026, is one of 86 in phase 3, reaches primary completion later than 88 of the 124 other live ones, and was the 640th registered.

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

Browse Macular Degeneration studies →

Open to participants now

85 of the 645 studies in Macular Degeneration with a site in United States are open now. Recruiting first, the newest first:

79 more — sign in →

All 85 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.

This study: 55 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 645 studies in Macular Degeneration with a site in United States, or all of them as a file.
02

Study summary

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

Read the detailed description

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 either of the following arms:

Treatment arm (OCU410) study subjects will receive single subretinal injection of 200 µL, OCU410 in the study eye with the optimal dose (N=158)

Control arm (untreated) (N=79)

A total of 237 subjects will be enrolled in the study. Subjects who are enrolled in the untreated control group of the study will not receive any treatment. Subjects randomized to the treatment arm may receive a single subretinal injection of OCU410 in the study eye, provided they meet all treatment eligibility criteria. Subjects who are randomized to the control arm will not receive any intervention during the initial 52 weeks (12 Months) of the study.

03

Conditions studied

  • Dry Age-related Macular Degeneration

Keywords

  • Geographical Atrophy
  • Dry Age Related
04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects 55 years of age or older at consent.
  2. BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye.
  3. Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas [DA], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety, and not contiguous with any areas of peripapillary atrophy.
  4. Subjects with history of CNV diagnosis (inactive) in the fellow eye for ≥2 years prior to Screening; stable and treated CNV treatment prior to screening (stable and inactive); no active exudation at screening (confirmed by imaging at the discretion of the investigator)
  5. Subjects who had prior treatment with an approved drug for AMD, e.g. Izervay® (avacincaptad pegol) or Syfovre® (pegcetacoplan injection) can be included, after a of at least 3 months in study eye from screening visit. Subjects can receive an approved drug for AMD in the fellow eye, if required.

Exclusion criteria

Exclusion Criteria:

  1. Previous treatment with a gene-therapy or cell therapy product.
  2. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
  3. Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.
  4. Any history or current evidence of exudative ("wet") AMD in the study eye including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram. Subjects with active exudative CNV in the fellow eye will be exclude.
  5. Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
237 participants (estimated)

Study arms

  • Experimental
    OCU410

    OCU410 Single Sub Retinal Injection, 200 µL, 1×10\^10 vg/eye

    Biological: OCU410

  • No intervention
    Untreated Control Arm

    Control Arm (Untreated)

Interventions

  • BiologicalOCU410

    Subretinal Injection

06

What researchers measure

Primary outcomes

  1. Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12

    Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements

    Time frame: Month 12

Secondary outcomes

  1. Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12

    Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12 as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual charts

    Time frame: Month 12

  2. Rate of change of ellipsoid zone (EZ) area loss at Month 12

    Rate of change of ellipsoid zone (EZ) area loss over Month 12 as assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)

    Time frame: Month 12

07

Study locations

1 of 3 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 77 industry-sponsored phase 3 interventional studies under Macular Degeneration, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 23 months is close to that.

Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 20 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 18, 2026
StartActual
Aug 11, 2026
Primary completionEst.
Jul 30, 2028
CompletionEst.
Jul 30, 2031
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07770828
Lead sponsor
Ocugen
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Aug 11, 2026
Primary completion
Jul 30, 2028 (estimated)
Completion
Jul 30, 2031 (estimated)
Last update
Aug 19, 2026

Study contacts

Umair Qazi, MD., MPH
Contact
umair.qazi@ocugen.com
12028170787
Payton Marvel, M.S
Contact
payton.marvel@ocugen.com
484-443-3200
Mohamed Genead, MD
study chair · Ocugen., Inc.
Jennifer Henrick
study director · Ocugen., Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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