RECRUITING

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)

Conditions

Geographic Atrophy Age-related Macular Degeneration

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-07-16

Study Completion:2027-01-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06961370

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.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * 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

Inclusion Criteria

Exclusion 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

* 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
* 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

Contacts and Locations

Study Contact

Reference Study ID Number: BP45482 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Associated Retina Consultants - Phoenix - DocTrials - PPDS

Phoenix, Arizona, 85020-5505

United States

Barnet Dulaney Perkins Eye Center

Sun City, Arizona, 85351

United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211

United States

Global Research Management

Glendale, California, 91204

United States

Retinal Consultants Medical Group Inc - Parkcenter Drive

Sacramento, California, 95825

United States

Southeast Retina Center

Augusta, Georgia, 30909

United States

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740

United States

The Retina Institute

St Louis, Missouri, 63128

United States

Retina Northwest

Portland, Oregon, 97221

United States

Erie Retina Research

Erie, Pennsylvania, 16505

United States

Charles Retina Institute

Germantown, Tennessee, 38138

United States

Tennessee Retina PC

Nashville, Tennessee, 37203

United States

Austin Clinical Research, LLC

Austin, Texas, 78750

United States

Texas Retina Associates

Dallas, Texas, 75231

United States

Retina Consultants of Texas Westover Hills Retina Center

San Antonio, Texas, 78251

United States

Retina Consultants of Texas - (The Woodlands)

The Woodlands, Texas, 77384

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16

Study Completion Date2027-01-03

Study Record Updates

Study Start Date2025-07-16

Study Completion Date2027-01-03

Terms related to this study

Additional Relevant MeSH Terms

Geographic Atrophy
Age-related Macular Degeneration