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)
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studieren Sie die Kontaktsicherung
- Name: Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-Mail: global-roche-genentech-trials@gene.com
Studienorte
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California
-
Walnut Creek, California, Vereinigte Staaten, 94598-5915
- Rekrutierung
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27103-6945
- Rekrutierung
- Piedmont Retina Specialists
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Pennsylvania
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Erie, Pennsylvania, Vereinigte Staaten, 16505
- Rekrutierung
- Erie Retina Research
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Texas
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Arlington, Texas, Vereinigte Staaten, 76012-2505
- Rekrutierung
- Texas Retina Associates - Arlington
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Virginia
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Lynchburg, Virginia, Vereinigte Staaten, 24502-4271
- Rekrutierung
- Piedmont Eye Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Placebo
Participants will receive placebo. |
Placebo will be administered as per the schedule defined in the protocol. |
|
Experimental: RO7965032 Dose Level 1
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
|
Experimental: RO7965032 Dose Level 2
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Zeitfenster: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Ocular Adverse Events (AEs)
Zeitfenster: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Incidence and Severity of Non-Ocular AEs
Zeitfenster: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Zeitfenster: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Plasma Concentration of RO7965032
Zeitfenster: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Target Protein in Plasma
Zeitfenster: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Plasma Biomarker Activity
Zeitfenster: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Zeitfenster: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Recommended Dose of RO7965032
Zeitfenster: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- XR46785
- 2026-527027-10-00 (Ctis)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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