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)
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sauvegarde des contacts de l'étude
- Nom: Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
- Numéro de téléphone: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Lieux d'étude
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California
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Walnut Creek, California, États-Unis, 94598-5915
- Recrutement
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27103-6945
- Recrutement
- Piedmont Retina Specialists
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Pennsylvania
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Erie, Pennsylvania, États-Unis, 16505
- Recrutement
- Erie Retina Research
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Texas
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Arlington, Texas, États-Unis, 76012-2505
- Recrutement
- Texas Retina Associates - Arlington
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Virginia
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Lynchburg, Virginia, États-Unis, 24502-4271
- Recrutement
- Piedmont Eye Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
Participants will receive placebo. |
Placebo will be administered as per the schedule defined in the protocol. |
|
Expérimental: RO7965032 Dose Level 1
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
|
Expérimental: RO7965032 Dose Level 2
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Délai: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Ocular Adverse Events (AEs)
Délai: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Incidence and Severity of Non-Ocular AEs
Délai: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change of GA Lesion Area in the Study Eye
Délai: 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
Délai: 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
Délai: Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
Délai: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Plasma Concentration of RO7965032
Délai: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Target Protein in Plasma
Délai: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Plasma Biomarker Activity
Délai: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
Délai: Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Recommended Dose of RO7965032
Délai: Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- XR46785
- 2026-527027-10-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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