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New treatment option for Geographic Atrophy Secondary to Age-related Macular Degeneration
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)
ClinicalTrials.gov ID: NCT07392255
What this study is testing
What is CTx001?
CTx001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for geographic atrophy secondary to age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment clinical study or exposure to investigational therapies
- Any condition that, in the investigator's judgment, poses unacceptable risk or precludes safe participation
The study team makes the final eligibility decision.
Where it's taking place
- Carmel, Indiana, United States
- Reno, Nevada, United States
- Dallas, Texas, United States
- La Crosse, Wisconsin, United States
- London, London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carmel, Indiana, United States; Reno, Nevada, United States; Dallas, Texas, United States; La Crosse, Wisconsin, United States; London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.