Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD
NCT00574093 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2009-10-30
Summary
This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne® \[verteporfin for injection\] and Lucentis™) on visual acuity outcomes. Study results will be submitted for publication to provide data that may help physicians refine the clinical management of patients with CNV secondary to age-related macular degeneration (AMD).
Conditions
- Neovascular Age Related Macular Degeneration
Interventions
- DRUG
-
Ranibizumab; Verteporfin
Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.
Sponsors & Collaborators
-
Fondazione G.B. Bietti, IRCCS
lead OTHER
Principal Investigators
-
Monica Varano, MD · Fondazione G.B. Bietti, IRCCS
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2009-06-30
- Completion
- 2009-10-31
Countries
- Italy
Study Locations
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