CTx001-01 (Opti-Gain)

Purpose of this Study

At various visits, you will have blood tests, eye exams, and vision tests.

Who Can Participate?

Eligibility

Copilot said: Here is a summary for a 5th grade audience, without contractions, apostrophes, or bullet points: People can join this study if they are older adults. Some parts of the study include people age 65 and older, and other parts include people age 55 and older. They must have a vision problem called geographic atrophy caused by age related macular degeneration. They cannot have had previous treatments for this condition in the study eye, except for vitamin supplements. They also cannot have had any gene therapy or cell therapy treatments before.

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 medicine called CTx001 for people who have a vision problem called geographic atrophy, which is caused by age related macular degeneration. Researchers want to find the best dose of this medicine and learn if it is safe and works well. The goal is to see if CTx001 can help slow down or improve this eye condition.

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