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)

Roche

Status and phase: Begins enrollment this month; Phase 1

Conditions: Geographic Atrophy; Age-related Macular Degeneration

Treatments: Drug: Izervay™; Drug: Syfovre™; Drug: RO7669330

Study type: Interventional

Funder types: Industry

Identifiers

NCT06961370

BP45482

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 3 patient groups

Part 1A: Multiple Ascending Dose (MAD)

Experimental group

Description:

Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.

Treatment:

Drug: RO7669330

Part 1B: Syfovre and Izervay

Experimental group

Description:

Participants will receive either Syfovre 15 milligrams (mg) or Izervay 2 mg, as an IVT injection in the study eye.

Treatment:

Drug: Syfovre™

Drug: Izervay™

Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)

Experimental group

Description:

Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.

Treatment:

Drug: RO7669330

Drug: Syfovre™

Drug: Izervay™