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NCT06961370TerminatedPhase 1

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 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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Reason given: The study was terminated prematurely by the Sponsor due to observation of dose-limiting adverse events meeting the protocol-defined stopping criteria.

Brief summary (registry, in English)

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in participants with GA secondary to AMD in at least one eye in Part 1, or both eyes in Part 2, after multiple unilateral intravitreal (IVT) doses.

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
27 (actual)
First submitted
29 Apr 2025
Start date
16 Jul 2025
Primary completion date
3 Feb 2026
Lead sponsor
Hoffmann-La Roche
NCT number
NCT06961370

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Active or history of CNV
    • Ocular Exclusion Criteria for the Non-Study Eye:

Other

  • Ocular Exclusion Criteria for the Study Eye:
  • Aphakic or pseudophakic with intraocular lens outside of the capsular bag
  • 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

Who the study is looking for

  • 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

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Southeast Retina CenterAugustaUnited StatesUnknown status
Austin Clinical Research, LLCAustinUnited StatesUnknown status
Retina - Vitreous Associates Medical Group, PCBeverly HillsUnited StatesUnknown status
Texas Retina AssociatesDallasUnited StatesUnknown status
Erie Retina ResearchErieUnited StatesUnknown status
Charles Retina InstituteGermantownUnited StatesUnknown status
Global Research ManagementGlendaleUnited StatesUnknown status
Cumberland Valley Retina Consultants PCHagerstownUnited StatesUnknown status
Tennessee Retina, PCNashvilleUnited StatesUnknown status
Associated Retina Consultants - Phoenix - DocTrials - PPDSPhoenixUnited StatesUnknown status
Retina NorthwestPortlandUnited StatesUnknown status
Retinal Consultants Medical Group Inc - Parkcenter DriveSacramentoUnited StatesUnknown status
Retina Consultants of Texas Westover Hills Retina CenterSan AntonioUnited StatesUnknown status
Deep Blue Retina Clinical ResearchSouthavenUnited StatesUnknown status
The Retina InstituteSt LouisUnited StatesUnknown status
Barnet Dulaney Perkins Eye CenterSun CityUnited StatesUnknown status
Retina Consultants of Texas - The WoodlandsThe WoodlandsUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.