Clinical trial NCT06961370: 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)
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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Geographic Atrophy
Age-related Macular Degeneration
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 132
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1A will be a single group study, while Part 1B and Part 2 will follow a parallel-group design.
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to a maximum of 32 weeks
measure: Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments
timeFrame: Up to a maximum of 32 weeks
Secondary outcomes:
measure: Part 1A and Part 2: Ocular and Systemic Concentration of RO7669330
timeFrame: Up to a maximum of Week 24
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: