Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You
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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in participants with GA secondary to AMD in at least one eye in Part 1, or both eyes in Part 2, after multiple unilateral intravitreal (IVT) doses.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:
• 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 ≤ 20 mm\^2 )
Retinal Consultants Medical Group Inc - Parkcenter Drive
RECRUITING
Sacramento
Georgia
Southeast Retina Center
RECRUITING
Augusta
Maryland
Cumberland Valley Retina Consultants PC
RECRUITING
Hagerstown
Missouri
The Retina Institute
RECRUITING
St Louis
Oregon
Retina Northwest
RECRUITING
Portland
Pennsylvania
Erie Retina Research
RECRUITING
Erie
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Tennessee Retina PC
RECRUITING
Nashville
Texas
Austin Clinical Research, LLC
RECRUITING
Austin
Texas Retina Associates
RECRUITING
Dallas
Retina Consultants of Texas Westover Hills Retina Center
RECRUITING
San Antonio
Retina Consultants of Texas - (The Woodlands)
RECRUITING
The Woodlands
Contact Information
Primary
Reference Study ID Number: BP45482 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date:2025-07-16
Estimated Completion Date:2027-01-03
Participants
Target number of participants:132
Treatments
Experimental: Part 1A: Multiple Ascending Dose (MAD)
Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.
Experimental: Part 1B: Syfovre and Izervay
Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.
Experimental: Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)
Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.