OCU410 for Age-Related Macular Degeneration

(ArMaDa Trial)

Recruiting at10 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Ocugen

Disqualifiers: Gene therapy, Cell therapy, Wet AMD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 3 months for those who had prior treatment with approved drugs for AMD, like Izerway® or Syfovre®. For other medications, the protocol does not specify if you need to stop taking them.

Research Team

Murthy Chavali, Ph.D

Principal Investigator

Ocugen

Eligibility Criteria

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.

Inclusion Criteria

Your total GA area is between 2.5 and 17.5 mm2, equivalent to 1-7 disk areas (DA).

I am 50 years old or older.

Your visual acuity is at least 24 letters or higher according to the ETDRS chart (equivalent to 20/320 on a Snellen scale).

Exclusion Criteria

I haven't used experimental drugs or devices in the last year.

My vision loss is not due to AMD but another condition like Stargardt disease.

I have been treated with Syfovre before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Open-label, dose-ranging/dose-escalating study with a 3+3 design enrolling up to 18 subjects. Participants receive a single subretinal injection of OCU410.

12 months

Multiple visits for dose escalation and monitoring

Phase 2 Treatment

Randomized dose-expansion cohort with 45 subjects in a 1:1:1 ratio to two treatment arms or control. Participants receive a single subretinal injection of OCU410.

12 months

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of visual acuity and immune response.

12 months

Treatment Details

Interventions

• OCU410 (Gene Therapy)

Trial Overview 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.

Participant Groups

Group I: Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL): Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 Intervention

Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration.

Group VI: Control Arm Active Control 1 Intervention

No Intervention Control Arm: Subject will not receive any active study intervention

Who Is Running the Clinical Trial?

Ocugen

Lead Sponsor

Trials

12

Recruited

1,100+