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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months (screening to 12 months post ocu410 administration)

Awards & highlights

ArMaDa Trial Summary

This trial will assess the safety and effectiveness of a potential treatment for vision loss due to Age-Related Macular Degeneration.

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.Check my eligibility

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.See study design

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.

ArMaDa Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

ArMaDa Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months (screening to 12 months post ocu410 administration)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Humoral and cellular immune response

Laboratory parameters including serum chemistry and hematology

Shedding of viral vector

Other outcome measures

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

ArMaDa 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OcugenLead Sponsor

9 Previous Clinical Trials

1,004 Total Patients Enrolled

Huma Qamar, MD, MPH, CMIStudy DirectorOcugen

3 Previous Clinical Trials

566 Total Patients Enrolled

Murthy Chavali, Ph.DStudy DirectorOcugen

1 Previous Clinical Trials

42 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted into this experiment at present?

"This clinical trial is now recruiting participants, according to information found on the website. The initial post date was August 23rd 2023 and it has been recently amended as late as August 25th 2023."

Answered by AI

How many participants are currently enrolled in this clinical research?

"Affirmative. The details stored on clinicaltrials.gov indicate that this inquiry, which was initially posted on August 23rd 2023, is presently looking for participants. Sixty-three individuals need to be recruited from two different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy

2023. "Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018558.

All > Geographic Atrophy