OCU410-101 (Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration)

Purpose of this Study

We are doing this study to find out if an experimental gene transfer drug called OCU410 (the study drug) is a safe and effective option for geographic atrophy secondary to dry age-related macular degeneration.

Who Can Participate?

Eligibility

Adults ages 50+ who:
  • Are diagnosed with geographic atrophy
  • Have never received a gene therapy or cell therapy product to treat vision problems
  • Do not smoke
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Range

50-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join the study, you will receive:
  • Either a low dose, or a medium dose, or a high dose of the study drug; OR
  • You will receive a placebo (inactive substance with no drug in it) and be in the control group
You will be in touch with the study team for about 15 months and you will visit our clinic at the Duke Eye Center up to 8 times. At various visits, you will have blood tests, eye exams, and vision tests.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. OCU410-101

Principal Investigator

Majda
Hadziahmetovic

Protocol Number

PRO00114282

NCT ID

NCT06018558

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov