Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD

Macular Degeneration Clinical Trial

Official title: Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD

Status Terminated

Clinical Trial Summary

The purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total lesion area).

To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence:

300 mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600 mW/cm2) in patients whose neovascular CNV lesions containing >50% blood.

Clinical Trial Description

This is a phase one study in patients with all CNV lesion subtypes who are naïve to previous treatment. Lesions must have blood as a primary component (i.e., contain more than 50% blood). Patients will receive one of two combination treatments:

• Verteporfin PDT reduced fluence (300 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection

• Verteporfin PDT standard fluence (600 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection A total of 10 patients will be enrolled, 5 per treatment arm. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

• NCT number: NCT00403442
• Study type: Interventional
• Source: Vitreous -Retina- Macula Consultants of New York
• Status: Terminated
• Phase: Phase 1
• Start date: September 2006