Clareo Health | A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
55–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 )
Part 2: ≥ 2.5 mm\^2 and ≤ 20 mm\^2
You may not be if
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
Active or history of CNV
\- Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye
Macular atrophy in either eye due to causes other than AMD
Part 2: 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 ≤ 20 weeks prior to Day 1. For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1
