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)

Description

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.

Conditions

Geographic Atrophy, Age-related Macular Degeneration

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Study Overview

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Study Details

Study overview

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.

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

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)

Condition
Geographic Atrophy
Intervention / Treatment

-

Contacts and Locations

Glendale

Global Research Management, Glendale, California, United States, 91204

Augusta

Southeast Retina Center, Augusta, Georgia, United States, 30909

Erie

Erie Retina Research, Erie, Pennsylvania, United States, 16507-1429

Germantown

Charles Retina Institute, Germantown, Tennessee, United States, 38138

Dallas

Texas Retina Associates, Dallas, Texas, United States, 75231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2027-01-03