Actively Recruiting
Study to Evaluate Safety and Effects of CTx001 by Subretinal Injection for Geographic Atrophy Secondary to Age-Related Macular Degeneration
Led by Complement Therapeutics · Updated on 2026-05-04
75
Participants Needed
4
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of CTx001 for patients with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This clinical trial is a first-in-human Phase 1/2 multi-center study that uses a single subretinal injection of CTx001. Participants will be monitored for safety and efficacy over two years, followed by annual long-term safety assessments for up to five years. The study involves administering CTx001 once through a subretinal injection at three different dose levels. After this single treatment, patients will be followed regularly to assess how well they tolerate the treatment and to evaluate its safety. The main goal is to monitor the effects of CTx001 from the time of injection up to 52 weeks, with ongoing observations for longer-term safety. Participants will undergo various assessments including measurements of visual acuity, retinal sensitivity, and imaging tests such as fundus autofluorescence and SD-OCT to track lesion size and retinal health. These evaluations will help researchers understand the treatment's impact and ensure participant safety. The study requires participants to comply with all procedures and provide informed consent, with the total involvement potentially lasting up to five years.
CONDITIONS
Official Title
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 55 years or older
- Have bilateral geographic atrophy secondary to age-related macular degeneration confirmed by the Reading Center
- Meet baseline lesion size requirements assessed by fundus autofluorescence imaging
- Meet best-corrected and low-luminance visual acuity criteria measured by ETDRS charts
- Meet retinal sensitivity criteria measured by microperimetry
- Have sufficient fellow-eye visual function for navigational vision
- Have adequate historical SD-OCT imaging available for longitudinal assessment
- Meet reproductive status and contraception requirements if applicable
- Be able and willing to provide informed consent and comply with study procedures
You will not qualify if you...
- Have macular atrophy or retinal disease not caused by age-related macular degeneration
- Have evidence of current or prior choroidal neovascularization (wet AMD)
- Have had prior intraocular, macular, or retinal surgery or laser treatment that could affect assessments
- Have had prior AMD-directed or intravitreal therapy in the study eye except permitted supplements
- Have prior exposure to complement inhibitor therapies
- Have ocular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging
- Have uncontrolled glaucoma, diabetic retinopathy, or significant refractive error
- Have aphakia or compromised posterior capsule except as permitted by protocol
- Have systemic medical or psychiatric conditions that increase risk or limit compliance
- Have recently participated in another interventional clinical study or received investigational therapies
- Have any condition that poses unacceptable risk or prevents safe participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Midwest Eye Institute
Carmel, Indiana, United States, 46290
Actively Recruiting
2
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
3
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Actively Recruiting
4
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
M
Muhammad Ali Memon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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