Second Line Therapy to Treat Age-related Macular Degeneration (AMD) for Patients Not Responding Well to Lucentis Therapy by Itself

• Status: Withdrawn
• Trial end date: 2007-12-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D) triple therapy will give similar efficacy and safety results as Lucentis monotherapy.

• Phase: Phase 2

Details

• Lead Sponsor: Vitreous -Retina- Macula Consultants of New York
• Collaborator: QLT Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ranibizumab; Verteporfin

Criteria

Main Inclusion Criteria:

• Patients with subfoveal CNV due to AMD who, after 2-6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4-8 weeks after the last treatment. Exudative activity is defined as one or more of:

• CNV leakage confirmed by FA

• New hemorrhage associated with the CNV lesion

• Subretinal fluid or cystoid macular edema by OCT showing retinal thickness ≥ 230 μm

• All lesion composition types with a lesion greatest linear dimension (GLD) ≤ 5400 microns (approximately ≤ 9 disc areas [DA])

• Best corrected ETDRS VA score of 25-73 letters (approximate Snellen equivalent of 20/40-20/320)

Main Exclusion Criteria:

• Subfoveal geographic atrophy or subfoveal fibrosis in the study eye

• Intraocular surgery within 3 months of enrollment

• Inability to attend the protocol-required visits

• Known allergies or hypersensitivity to any of the study treatments