Investigating a new treatment for geographic atrophy due to age-related macular degeneration
A Phase I, Multi-center, Multi-part Study to Investigate Safety, Tolerability, PK, PD, and Immunogenicity of RO7669330 Intravitreal Injections in Participants With GA Secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD Pilot; Part 2: Masked, Randomized, Active-comparator-controlled
This study is testing a new treatment for geographic atrophy caused by age-related macular degeneration to see how safe it is and how well it works for patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 5 sites (Glendale, California and 4 other locations) |
| Trial ID | NCT06961370 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of RO7669330 in patients with geographic atrophy secondary to age-related macular degeneration. Participants will receive multiple unilateral intravitreal doses of the treatment, and the study will assess both ocular and systemic effects. The research aims to gather data on how well the treatment works and its potential side effects.
Who should consider this trial
Good fit: Ideal candidates include individuals with geographic atrophy that meets specific imaging and visual acuity criteria.
Not a fit: Patients with certain ocular conditions or previous treatments that may interfere with the study outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients suffering from geographic atrophy due to age-related macular degeneration.
How similar studies have performed: Other studies have explored treatments for age-related macular degeneration, but the specific approach of this trial is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adequately clear ocular media, adequate pupillary dilation, and fixation to allow acquisition of good quality fundus imaging * GA that resides completely within the fundus autofluorescence (FAF) imaging field * Presence of hyperautofluorescence of either banded or diffuse pattern adjacent to the GA area on FAF * Study eye has early treatment of diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) score as follows: * Part 1A: 19 to 48 letters inclusively * Part 1B: \> 19 letters * Part 2: ≥ 24 letters * Total GA lesion size must be as follows: * Parts 1A and 1B: ≥ 1.25 square millimeter (mm\^2) and ≤ 17.5 mm\^2 ) * Part 2: ≥ 2.5 mm\^2 and ≤ 17.5 mm\^2 Exclusion Criteria: Ocular Exclusion Criteria for the Study Eye: * Aphakic or pseudophakic with intraocular lens outside of the capsular bag * Previous laser photocoagulation or IVT anti-vascular endothelial growth factor (VEGF) for CNV, diabetic macular edema (DME), retinal vein occlusion (RVO), or proliferative diabetic retinopathy Ocular Exclusion Criteria for the Non-Study Eye: - Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye Ocular Exclusion Criteria for Both Eyes: * Macular atrophy in either eye due to causes other than AMD * Evidence of prior or active CNV * Prior treatment with any approved therapy for GA (Syfovre, Izervay) in either eye for Part 1A and Part 2. For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1
Where this trial is running
Glendale, California and 4 other locations
- Global Research Management — Glendale, California, United States (Recruiting)
- Southeast Retina Center — Augusta, Georgia, United States (Recruiting)
- Erie Retina Research — Erie, Pennsylvania, United States (Recruiting)
- Charles Retina Institute — Germantown, Tennessee, United States (Recruiting)
- Texas Retina Associates — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BP45482 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.