Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: 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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Associated Retina Consultants - Phoenix - DocTrials - PPDS, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ≤ 20 mm^2 )
  • Part 2: ≥ 2.5 mm^2 and ≤ 20 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
  • Active or history of CNV

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
  • 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

Treatment and study plan

RO7669330

Drug

RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

Syfovre™

Drug

Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

Other names: Pegcetacoplan injection

Izervay™

Drug

Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

Other names: Avacincaptad pegol IVT solution

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to a maximum of 34 weeks

  2. Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments

    Time frame: Up to a maximum of 34 weeks

    The standard ophthalmological assessments that will be conducted may include the following: slit-lamp, indirect ophthalmology, intraocular pressure (IOP), best corrected visual acuity (BCVA), spectral domain optical coherence tomography (SD-OCT), fundus fluorescein angiography (FFA), and color fundus photography (CFP).

Secondary outcomes

  1. Part 1A and Part 2: Ocular and Systemic Concentration of RO7669330

    Time frame: Up to a maximum of Week 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 7, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.