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)
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-post: global-roche-genentech-trials@gene.com
Studiesteder
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California
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Walnut Creek, California, Forente stater, 94598-5915
- Rekruttering
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27103-6945
- Rekruttering
- Piedmont Retina Specialists
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Pennsylvania
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Erie, Pennsylvania, Forente stater, 16505
- Rekruttering
- Erie Retina Research
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Texas
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Arlington, Texas, Forente stater, 76012-2505
- Rekruttering
- Texas Retina Associates - Arlington
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Virginia
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Lynchburg, Virginia, Forente stater, 24502-4271
- Rekruttering
- Piedmont Eye Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Participants will receive placebo. |
Placebo will be administered as per the schedule defined in the protocol. |
|
Eksperimentell: RO7965032 Dose Level 1
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
|
Eksperimentell: RO7965032 Dose Level 2
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Tidsramme: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Ocular Adverse Events (AEs)
Tidsramme: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Incidence and Severity of Non-Ocular AEs
Tidsramme: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Tidsramme: Baseline up to approximately 72 weeks
|
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
Tidsramme: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
Tidsramme: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Tidsramme: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Plasma Concentration of RO7965032
Tidsramme: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Target Protein in Plasma
Tidsramme: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Plasma Biomarker Activity
Tidsramme: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Tidsramme: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Recommended Dose of RO7965032
Tidsramme: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- XR46785
- 2026-527027-10-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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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