Geographic Atrophy Secondary to Age-Related Macular DegenerationPhase 2NCT07851259
A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Phase 2 study testing RO7965032 in people with Geographic Atrophy Secondary to Age-Related Macular Degeneration, run by Genentech, Inc. at 5 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy Secondary to Age-Related Macular Degeneration
- What is being tested?
- RO7965032
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jan 2027to 21 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below. contact
Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Texas Retina Associates - Arlington
Arlington, Texas, 76012-2505
- Recruiting
Erie Retina Research
Erie, Pennsylvania, 16505
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502-4271
- Recruiting
Bay Area Retina Specialists Medical Group - Vestrum - PPDS
Walnut Creek, California, 94598-5915
- Recruiting
Piedmont Retina Specialists
Winston-Salem, North Carolina, 27103-6945
About this study
Official title: A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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)
- Being tested
- RO7965032, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7965032Drug
RO7965032 will be administered as per the schedule defined in the protocol.
PlaceboDrug
Placebo will be administered as per the schedule defined in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7965032 Dose Level 1 | Experimental | Participants will receive RO7965032. Receives: Drug: RO7965032 |
| RO7965032 Dose Level 2 | Experimental | Participants will receive RO7965032. Receives: Drug: RO7965032 |
| Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of GA Lesion Area in the Study Eye
Measured: Baseline up to approximately 48 weeks
Incidence and Severity of Ocular Adverse Events (AEs)
Measured: Up to approximately 72 Weeks
Incidence and Severity of Non-Ocular AEs
Measured: Up to approximately 72 Weeks
Secondary outcomes (9)
Change of GA Lesion Area in the Study Eye
Measured: Baseline up to approximately 72 weeks
Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Measured: Baseline up to approximately 48 weeks
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
Measured: Baseline up to approximately 48 weeks
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Measured: Up to approximately 72 Weeks
Plasma Concentration of RO7965032
Measured: Baseline up to approximately 72 weeks
Percent Change from Baseline in Levels of Target Protein in Plasma
Measured: Baseline up to approximately 72 weeks
Percent Change from Baseline in Levels of Plasma Biomarker Activity
Measured: Baseline up to approximately 72 weeks
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Measured: Baseline up to approximately 72 weeks
Recommended Dose of RO7965032
Measured: Up to approximately 72 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start8 Jan 2027 (estimated)
- Primary completion21 Aug 2030 (estimated)
- Study completion21 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Secondary to Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851259
- Sponsor's protocol ID
- XR46785
- Other IDs
- 2026-527027-10-00
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07851259
- Acronym / sponsor ID
- XR46785
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2027 (estimated)
- Primary completion
- 21 Aug 2030 (estimated)
- Study completion
- 21 Aug 2030 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RO7965032 Dose Level 1 | Experimental | Drug: RO7965032Participants will receive RO7965032. |
| RO7965032 Dose Level 2 | Experimental | Drug: RO7965032Participants will receive RO7965032. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7965032RO7965032 will be administered as per the schedule defined in the protocol. | Drug | RO7965032 Dose Level 1, RO7965032 Dose Level 2 |
| PlaceboPlacebo will be administered as per the schedule defined in the protocol. | Drug | Placebo |
Primary outcome
Change of GA Lesion Area in the Study Eye
Time frame: Baseline up to approximately 48 weeks
Incidence and Severity of Ocular Adverse Events (AEs)
Time frame: Up to approximately 72 Weeks
Incidence and Severity of Non-Ocular AEs
Time frame: Up to approximately 72 Weeks
9 secondary outcomes
Change of GA Lesion Area in the Study Eye
Time frame: Baseline up to approximately 72 weeks
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
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
Time frame: Baseline up to approximately 48 weeks
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Time frame: Up to approximately 72 Weeks
Plasma Concentration of RO7965032
Time frame: Baseline up to approximately 72 weeks
Percent Change from Baseline in Levels of Target Protein in Plasma
Time frame: Baseline up to approximately 72 weeks
Percent Change from Baseline in Levels of Plasma Biomarker Activity
Time frame: Baseline up to approximately 72 weeks
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Baseline up to approximately 72 weeks
Recommended Dose of RO7965032
Time frame: Up to approximately 72 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below. contact
Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO7965032 in people with Geographic Atrophy Secondary to Age-Related Macular Degeneration, run by Genentech, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of GA Lesion Area in the Study Eye (time frame: Baseline up to approximately 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.