A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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)
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studie Contact Back-up
- Naam: Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
- Telefoonnummer: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Studie Locaties
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California
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Walnut Creek, California, Verenigde Staten, 94598-5915
- Werving
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27103-6945
- Werving
- Piedmont Retina Specialists
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Pennsylvania
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Erie, Pennsylvania, Verenigde Staten, 16505
- Werving
- Erie Retina Research
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Texas
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Arlington, Texas, Verenigde Staten, 76012-2505
- Werving
- Texas Retina Associates - Arlington
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Virginia
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Lynchburg, Virginia, Verenigde Staten, 24502-4271
- Werving
- Piedmont Eye Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
Participants will receive placebo. |
Placebo will be administered as per the schedule defined in the protocol. |
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Experimenteel: RO7965032 Dose Level 1
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
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Experimenteel: RO7965032 Dose Level 2
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Tijdsspanne: Baseline up to approximately 48 weeks
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Baseline up to approximately 48 weeks
|
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Incidence and Severity of Ocular Adverse Events (AEs)
Tijdsspanne: Up to approximately 72 Weeks
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Up to approximately 72 Weeks
|
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Incidence and Severity of Non-Ocular AEs
Tijdsspanne: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Tijdsspanne: Baseline up to approximately 72 weeks
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Baseline up to approximately 72 weeks
|
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Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Tijdsspanne: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
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Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
Tijdsspanne: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
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Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Tijdsspanne: Up to approximately 72 Weeks
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Up to approximately 72 Weeks
|
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Plasma Concentration of RO7965032
Tijdsspanne: Baseline up to approximately 72 weeks
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Baseline up to approximately 72 weeks
|
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Percent Change from Baseline in Levels of Target Protein in Plasma
Tijdsspanne: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
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Percent Change from Baseline in Levels of Plasma Biomarker Activity
Tijdsspanne: Baseline up to approximately 72 weeks
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Baseline up to approximately 72 weeks
|
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Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Tijdsspanne: Baseline up to approximately 72 weeks
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Baseline up to approximately 72 weeks
|
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Recommended Dose of RO7965032
Tijdsspanne: Up to approximately 72 Weeks
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Up to approximately 72 Weeks
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- XR46785
- 2026-527027-10-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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