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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)
Eye Disorder Age-Related Macular Degeneration Dry Macular Degeneration Geographic Atrophy
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Study Identifier
NCT06961370, BP45482
Condition
Geographic Atrophy, Age-related Macular Degeneration
Official Title
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
Study Summary
The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal (IVT) doses.
Eligibility Criteria
All
≥55 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com