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:<ul>
<li>Are diagnosed with geographic atrophy</li>
<li>Have never received a gene therapy or cell therapy product to treat vision problems</li>
<li>Do not smoke</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu.</a>
<li>Are diagnosed with geographic atrophy</li>
<li>Have never received a gene therapy or cell therapy product to treat vision problems</li>
<li>Do not smoke</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu.</a>
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?
If you choose to join the study, you will receive:<ul>
<li>Either a low dose, or a medium dose, or a high dose of the study drug; OR</li>
<li>You will receive a placebo (inactive substance with no drug in it) and be in the control group</li></ul>
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.
<li>Either a low dose, or a medium dose, or a high dose of the study drug; OR</li>
<li>You will receive a placebo (inactive substance with no drug in it) and be in the control group</li></ul>
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