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)

Last updated: September 14, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1

Condition

Geographic Atrophy

Macular Degeneration

Aging

Treatment

Syfovre™

Izervay™

RO7669330

Clinical Study ID

NCT06961370
BP45482
  • Ages > 55
  • All Genders

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

Inclusion

Inclusion Criteria:

  • Adequately clear ocular media, adequate pupillary dilation, and fixation to allowacquisition 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 tothe GA area on FAF

  • Study eye has early treatment of diabetic retinopathy study (ETDRS) best-correctedvisual 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

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), orproliferative 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 eyefor Part 1A and Part 2. For Part 1B, prior treatment with any approved therapy forGA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1

Study Design

Total Participants: 132
Treatment Group(s): 3
Primary Treatment: Syfovre™
Phase: 1
Study Start date:
July 16, 2025
Estimated Completion Date:
January 03, 2027

Connect with a study center

  • Associated Retina Consultants - Phoenix - DocTrials - PPDS

    Phoenix, Arizona 85020-5505
    United States

    Site Not Available

  • Barnet Dulaney Perkins Eye Center

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Associated Retina Consultants - Phoenix - DocTrials - PPDS

    Phoenix 5308655, Arizona 5551752 85020-5505
    United States

    Active - Recruiting

  • Barnet Dulaney Perkins Eye Center

    Sun City 5316201, Arizona 5551752 85351
    United States

    Active - Recruiting

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Retinal Consultants Medical Group Inc - Parkcenter Drive

    Sacramento, California 95825
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills 5328041, California 5332921 90211
    United States

    Active - Recruiting

  • Global Research Management

    Glendale 5352423, California 5332921 91204
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group Inc - Parkcenter Drive

    Sacramento 5389489, California 5332921 95825
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta 4180531, Georgia 4197000 30909
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants PC

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Active - Recruiting

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • The Retina Institute

    St Louis 4407066, Missouri 4398678 63128
    United States

    Active - Recruiting

  • Retina Northwest

    Portland, Oregon 97221
    United States

    Site Not Available

  • Retina Northwest

    Portland 5746545, Oregon 5744337 97221
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie, Pennsylvania 16505
    United States

    Site Not Available

  • Erie Retina Research

    Erie 5188843, Pennsylvania 6254927 16505
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Tennessee Retina PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • Tennessee Retina PC

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Retina Consultants of Texas Westover Hills Retina Center

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Retina Consultants of Texas - (The Woodlands)

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin 4671654, Texas 4736286 78750
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Retina Consultants of Texas Westover Hills Retina Center

    San Antonio 4726206, Texas 4736286 78251
    United States

    Active - Recruiting

  • Retina Consultants of Texas - (The Woodlands)

    The Woodlands 4736476, Texas 4736286 77384
    United States

    Active - Recruiting

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