Purpose of this Study
Participants will receive the study drug in one eye during an outpatient surgery and will not need to stay in the hospital. Participation will last about 5 years and 5 months and includes 17 study visits, 1 phone visit, and regular tests and eye examinations.
Who Can Participate?
Eligibility
Participants may be able to join if they are older adults with geographic atrophy caused by age related macular degeneration. Depending on the study group, participants must be at least 55 or 65 years old. They cannot have received previous treatments for geographic atrophy in the study eye, except vitamin supplements, and cannot have received gene therapy or cell therapy in the past.
Age Range
55-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new treatment called CTx001 for people with geographic atrophy caused by age related macular degeneration. Researchers want to find the best dose, learn how safe the treatment is, and see how well it works to slow or treat the disease.
Locations
Duke University Hospital
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A First in Human Phase 1/2 Multi-center Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CTx001 Administered via a Single Subretinal Injection in Participants with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) - (Opti-Gain)
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00120577
Phase
I/II
Enrollment Status
Pending Open to Enrollment