60 Participants Needed

OCU410 for Age-Related Macular Degeneration

(ArMaDa Trial)

Recruiting at 13 trial locations
UQ
RG
BB
MJ
Overseen ByMichael J Borne, M.D
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Ocugen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MC

Murthy Chavali, Ph.D

Principal Investigator

Ocugen

Are You a Good Fit for This Trial?

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).
See 4 more

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • OCU410
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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Group I: Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL):Experimental Treatment1 Intervention
Group II: Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL):Experimental Treatment1 Intervention
Group III: Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL):Experimental Treatment1 Intervention
Group IV: Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized ArmExperimental Treatment1 Intervention
Group V: Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized ArmExperimental Treatment1 Intervention
Group VI: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ocugen

Lead Sponsor

Trials
12
Recruited
1,100+
Unbiased ResultsWe believe in providing patients with all the options.
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