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Gene Therapy

OCU410 for Age-Related Macular Degeneration (ArMaDa Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Ocugen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Subjects 50 years of age or older
Must not have
Previous treatment with Syfovre (Pegcetacoplan injection)
Previous treatment with a gene-therapy or cell therapy product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (screening to 12 months post ocu410 administration)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests OCU410, a gene therapy injected into the eye, for patients with severe vision loss due to advanced dry AMD. The treatment uses a virus to deliver helpful genes that may restore normal eye function.

Who is the study for?
This trial is for people aged 50 or older with a specific eye condition called Geographic Atrophy due to Dry Age-Related Macular Degeneration. Participants must have certain levels of vision and specific characteristics in their eye imaging. Those who've had recent investigational treatments, gene or cell therapies, or treatment with Syfovre are excluded.
What is being tested?
The study tests the safety and effectiveness of OCU410 in treating Geographic Atrophy. It's a two-phase study involving up to 63 subjects across multiple centers, aiming to see how well this new intervention works compared to current standards.
What are the potential side effects?
As this is an early phase trial (Phase 1/2), detailed side effects of OCU410 are not yet fully known but will be closely monitored throughout the study for any adverse reactions related to the eyes or general health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye condition can be fully captured in a detailed image without touching the optic nerve area.
Select...
I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with Syfovre before.
Select...
I have been treated with gene or cell therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (screening to 12 months post ocu410 administration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (screening to 12 months post ocu410 administration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in BCVA (Best Corrected Visual Acuity)
Change in Low Luminance Visual Acuity
Change in anatomy of ocular structures using Indirect ophthalmoscopy
+3 more
Secondary study objectives
Humoral and cellular immune response
Laboratory parameters including serum chemistry and hematology
Shedding of viral vector
Other study objectives
Change From Baseline in Mean Threshold Sensitivity (MAIA)
Change from Baseline in drusen volume using SD-OCT
Changes in National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ25)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL):Experimental Treatment1 Intervention
Medium Dose (5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the medium dose concentration.
Group II: Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL):Experimental Treatment1 Intervention
Low Dose (2.5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the low dose concentration.
Group III: Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL):Experimental Treatment1 Intervention
High Dose (1.5×10E11 vg/mL): Subjects will receive a subretinal injection in the high dose concentration.
Group IV: Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized ArmExperimental Treatment1 Intervention
Maximum tolerated dose (MTD) from Phase 1: Subjects will receive a subretinal injection in the MTD concentration.
Group V: Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized ArmExperimental Treatment1 Intervention
Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration.
Group VI: Control ArmActive Control1 Intervention
No Intervention Control Arm: Subject will not receive any active study intervention

Find a Location

Who is running the clinical trial?

OcugenLead Sponsor
11 Previous Clinical Trials
1,154 Total Patients Enrolled
Huma Qamar, MD, MPH, CMIStudy DirectorOcugen
4 Previous Clinical Trials
566 Total Patients Enrolled
Murthy Chavali, Ph.DStudy DirectorOcugen
1 Previous Clinical Trials
42 Total Patients Enrolled
~25 spots leftby Sep 2025
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