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Sponsored by: |
NeoVista |
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Information provided by: | NeoVista |
ClinicalTrials.gov Identifier: | NCT00809419 |
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.
Condition | Intervention | Phase |
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Age Related Macular Degeneration |
Device: NeoVista Ophthalmic System |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 32 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
NeoVista Ophthalmic System procedure + Lucentis or Avastin
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Device: NeoVista Ophthalmic System
A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) or Avastin (1.25mg) administered on an as needed basis for three years.
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Retina Consultants of Arizona | Recruiting |
Phoenix, Arizona, United States | |
Contact: Jennifer Cornelius clinicaltrials@neovistainc.com | |
Principal Investigator: Pravin Dugel, MD |
Responsible Party: | NeoVista, Inc. ( Jeffrey A. Nau, MMS, Director of Clinical Affairs ) |
Study ID Numbers: | NVI-008 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00809419 |
Health Authority: | United States: Food and Drug Administration |
Brachytherapy EpiRad Macular Degeneration Ranibizumab Bevacizumab |
Metaplasia Eye Diseases Choroid Diseases Retinal Degeneration Macular Degeneration |
Bevacizumab Neovascularization, Pathologic Retinal Diseases Retinal degeneration Choroidal Neovascularization |
Uveal Diseases Pathologic Processes |