NCT00809419

A Study of the NeoVista Ophthalmic System for the Treatment of Subfoveal CNV Associated With Wet AMD in Patients That Require Persistent Anti-VEGF Therapy

A Study of the NeoVista Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration in Patients That Require Persistent Anti-VEGF Therapy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: NeoVista · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of the MERITAGE Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD) in patients that require persistent injections of Anti-VEGF therapy to maintain an adequate response to treatment.

Detailed description

Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Brachytherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD. The current treatment for neovascualar AMD involves multiple injections over an indefinite period of time. This trial will evaluate whether treatment with brachytherapy can reduce or eliminate the need for continued injections.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	NeoVista Ophthalmic System	A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2008-12-17
• Last updated: 2011-07-27

Locations

5 sites across 3 countries: United States, Israel, United Kingdom