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Not yet recruitingNCT07851259Updated Oct 1, 2026

A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase 2 interventional study of RO7965032 and Placebo in Geographic Atrophy Secondary to Age-Related Macular Degeneration, sponsored by Genentech, Inc.. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 1, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

This study will assess the safety and efficacy of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

02

Conditions studied

  • Geographic Atrophy Secondary to Age-Related Macular Degeneration
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
321 participants (estimated)

Study arms

  • Experimental
    RO7965032 Dose Level 1

    Participants will receive RO7965032.

    Drug: RO7965032

  • Experimental
    RO7965032 Dose Level 2

    Participants will receive RO7965032.

    Drug: RO7965032

  • Placebo comparator
    Placebo

    Participants will receive placebo.

    Drug: Placebo

Interventions

  • DrugRO7965032

    RO7965032 will be administered as per the schedule defined in the protocol.

  • DrugPlacebo

    Placebo will be administered as per the schedule defined in the protocol.

06

What researchers measure

Primary outcomes

  1. Change of GA Lesion Area in the Study Eye

    Time frame: Baseline up to approximately 48 weeks

  2. Incidence and Severity of Ocular Adverse Events (AEs)

    Time frame: Up to approximately 72 Weeks

  3. Incidence and Severity of Non-Ocular AEs

    Time frame: Up to approximately 72 Weeks

Secondary outcomes

  1. Change of GA Lesion Area in the Study Eye

    Time frame: Baseline up to approximately 72 weeks

  2. Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart

    Time frame: Baseline up to approximately 48 weeks

  3. Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions

    Time frame: Baseline up to approximately 48 weeks

  4. Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging

    Time frame: Up to approximately 72 Weeks

  5. Plasma Concentration of RO7965032

    Time frame: Baseline up to approximately 72 weeks

  6. Percent Change from Baseline in Levels of Target Protein in Plasma

    Time frame: Baseline up to approximately 72 weeks

  7. Percent Change from Baseline in Levels of Plasma Biomarker Activity

    Time frame: Baseline up to approximately 72 weeks

  8. Prevalence and Incidence of Anti-Drug Antibodies (ADAs)

    Time frame: Baseline up to approximately 72 weeks

  9. Recommended Dose of RO7965032

    Time frame: Up to approximately 72 Weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07851259
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Oct 1, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Aug 21, 2030 (estimated)
Completion
Aug 21, 2030 (estimated)
Last update
Oct 1, 2026

Study contacts

Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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