Health TrialsbyHealthPanel

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

ConditionGeographic Atrophy Secondary to Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorGenentech, Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BCVA score of >= 35 letters using the ETDRS VA chart at a starting distance of 4 meters

Lesions may be either extrafoveal or subfoveal

Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

Well-demarcated GA secondary to AMD

Disqualifiers

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

Proliferative diabetic retinopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7965032

    Drug

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

  • Placebo

    Drug

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

Treatment groups

321 Participants
are divided into 3 treatment groups
Group A: RO7965032 Dose Level 1Experimental treatment 1 intervention
Group B: RO7965032 Dose Level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: