See if RO7965032 helps geographic atrophy from AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial assessing the safety and potential effectiveness of RO7965032 in participants with geographic atrophy caused by age-related macular degeneration. Eligible participants will have a starting visual acuity of at least 35 ETDRS letters in the study eye and well-demarcated GA with suitable ocular conditions for imaging. Participants will receive RO7965032 or placebo, with monitoring for safety and changes in vision and GA progression. The study is conducted at multiple retina specialty centers in the U.S., led by Genentech, Inc., and focuses on patients who meet specific ocular criteria while excluding those with certain retinal conditions or eye histories.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Ocular Inclusion Criteria for the Study Eye

* BCVA score of \>= 35 letters using the ETDRS VA chart at a starting distance of 4 meters
* Lesions may be either extrafoveal or subfoveal

Ocular Inclusion Criteria for Both Eyes

* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
* Well-demarcated GA secondary to AMD

Exclusion Criteria:

General Exclusion Criteria - History of hypersensitivity, a severe allergic reaction or anaphylactic reaction to any component of the investigational drug injection

Ocular Exclusion Criteria for the Study Eye

* History of diabetic macular edema (DME), retinal vein occlusion, corneal transplant, retinal detachment, Stage 3 or 4 macular hole, optic neuropathy, or retinal dystrophy
* Current or prior history of central serous retinopathy
* Aphakia or absence of the posterior capsule in the study eye

Ocular Exclusion Criteria for the Non-Study Eye

\- Non-functioning non-study eye defined as either BCVA of hand motion or worse or no physical presence of non-study eye (i.e., monocular)

Ocular Exclusion Criteria for Either Eye

* Proliferative diabetic retinopathy
* History of recurrent infectious or inflammatory ocular disease
* Current or prior history of choroidal neovascularization (CNV) in either eye
* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Other protocol-defined inclusion/exclusion criteria may apply

Where it's running

• Bay Area Retina Specialists Medical Group - Vestrum - PPDS
  Walnut Creek, California, United States Recruiting
• Piedmont Retina Specialists
  Winston-Salem, North Carolina, United States Recruiting
• Erie Retina Research
  Erie, Pennsylvania, United States Recruiting
• Texas Retina Associates - Arlington
  Arlington, Texas, United States Recruiting
• Piedmont Eye Center
  Lynchburg, Virginia, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• APL-3007 combined with Syfovre (pegcetacoplan) for geographic atrophy from age-related macular degeneration

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• Short-term progression of geographic atrophy in people with age-related macular degeneration

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• ADX-038 for geographic atrophy due to age-related macular degeneration

  This phase 2 study will test whether ADX-038 can slow geographic atrophy in people with age-related macular degeneration compared with placebo while monitoring safety and drug levels.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.