NCT07392255 An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
| NCT ID | NCT07392255 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Complement Therapeutics |
| Condition | Geographic Atrophy Secondary to Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 75 participants in total. It began in 2025-12-30 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD). Safety and efficacy will be measured at regular intervals for 2 years after which long-term safety will be assessed annually for up to 5 years.
Eligibility Criteria
Inclusion Criteria: Meet protocol-defined age eligibility Have bilateral geographic atrophy secondary to AMD, confirmed by the Reading Center Meet baseline lesion size requirements, as assessed by fundus autofluorescence imaging Meet best-corrected visual acuity and low-luminance visual acuity criteria, as measured by ETDRS charts Meet retinal sensitivity criteria, as measured by microperimetry Have sufficient fellow-eye visual function to ensure navigational vision Have adequate historical SD-OCT imaging available for longitudinal assessment Meet reproductive status and contraception requirements, where applicable Be able and willing to provide informed consent and comply with study procedures Exclusion Criteria: Macular atrophy or retinal disease not attributable to AMD Evidence of current or prior choroidal neovascularization (wet AMD) Prior intraocular, macular, or retinal surgery or laser treatment that may confound assessments Prior AMD-directed or intravitreal therapy in the study eye, except permitted supplements Prior exposure to complement inhibitor therapies Ocular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging Uncontrolled glaucoma, diabetic retinopathy, or clinically significant refractive error Aphakia or compromised posterior capsule, except as permitted by protocol Systemic medical or psychiatric conditions that may increase risk or limit compliance Recent participation in another interventional clinical study or exposure to investigational therapies Any condition that, in the investigator's judgment, poses unacceptable risk or precludes safe participation
Contact & Investigator
Muhammad Ali Memon
✉ clinicaltrials@complementtx.comFrequently Asked Questions
Who can join the NCT07392255 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Geographic Atrophy Secondary to Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07392255 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07392255 currently recruiting?
Yes, NCT07392255 is actively recruiting participants. Contact the research team at clinicaltrials@complementtx.com for enrollment information.
Where is the NCT07392255 trial being conducted?
This trial is being conducted at Carmel, United States, Reno, United States, Dallas, United States, La Crosse, United States and 4 additional locations.
Who is sponsoring the NCT07392255 clinical trial?
NCT07392255 is sponsored by Complement Therapeutics. The trial plans to enroll 75 participants.