BridgeMD
Study to Assess the Ability of ONL1204 to Slow the Progression of Atrophic Age-related Macular Degeneration
EU CTIS ID: 2024-513174-22-00
What this study is testing
To evaluate the efficacy of ONL1204 compared to sham injection in patients with geographic atrophy (GA) associated with AMD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 55 years of age or older at Screening.
- If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar [see Protocol for formulation]) nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or similar, patient must be willing to continue not to use therapy for the duration of the study. Patient must agree to choose either approach.
- Non-foveal GA associated with AMD without eMNV in the study eye per Investigator’s evaluation and as confirmed by the central RC.
- BCVA of 24 letters or more using ETDRS charts in the study eye at Screening.
- BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening.
You likely can't join if
- Any ocular or systemic condition that, in the opinion of the Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study.
- Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period.
- Previous IVT pharmaceutical treatment in the study eye with any agent except regionally approved complement inhibitors and treatment with regionally approved complement inhibitors within 12 weeks prior to Screening.
- Any current evidence or history in the study eye of exudative (“wet”) AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator’s evaluation and confirmed by the central RC.
- Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 13 and 14 pertaining to retinal and glaucoma surgery, respectively.
- Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than regionally approved complement inhibitors during the study period.
See the full eligibility criteria
- 55 years of age or older at Screening.
- If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar [see Protocol for formulation]) nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or similar, patient must be willing to continue not to use therapy for the duration of the study. Patient must agree to choose either approach.
- Non-foveal GA associated with AMD without eMNV in the study eye per Investigator’s evaluation and as confirmed by the central RC.
- BCVA of 24 letters or more using ETDRS charts in the study eye at Screening.
- BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening.
- Any ocular or systemic condition that, in the opinion of the Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study.
- Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period.
- Previous IVT pharmaceutical treatment in the study eye with any agent except regionally approved complement inhibitors and treatment with regionally approved complement inhibitors within 12 weeks prior to Screening.
- Any current evidence or history in the study eye of exudative (“wet”) AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator’s evaluation and confirmed by the central RC.
- Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 13 and 14 pertaining to retinal and glaucoma surgery, respectively.
- Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than regionally approved complement inhibitors during the study period.
- Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye.
- GA in either eye due to causes other than AMD.
- Any ophthalmic condition in either eye that is likely to require surgery during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Switzerland
- 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Switzerland; 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 EU CTIS; the study team decides eligibility.