Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD.
Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study).
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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California
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Bakersfield, California, États-Unis, 93309
- California Retina Consultants
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La Jolla, California, États-Unis, 92093
- Shiley Eye Center, UCSD
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Santa Barbara, California, États-Unis, 93103
- California Retina Consultants
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Texas
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San Antonio, Texas, États-Unis, 78240
- Medical Center Ophthalmology Associates
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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:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others
- Patients that have lost > 5 letters from baseline best vision
- BCVA 20/25-20/320
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study)
- Juxtafoveal and extrafoveal wet-AMD
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Ranibizumab 0.5 mg
Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
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0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months
Délai: Baseline, Month 6 and Month 12
|
PI is no longer affiliated with institution.
All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site.
Data from these participants is being reported here.
|
Baseline, Month 6 and Month 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.
Délai: Baseline, Month 6 and Month 12
|
Mean change was measured by letters gained or lost.
A positive number is letters gained, and a negative number is letters lost.
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Baseline, Month 6 and Month 12
|
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Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months
Délai: Baseline, Month 6 and Month 12
|
Baseline, Month 6 and Month 12
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Henry Ferreyra, MD, University of California, San Diego
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 110567
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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