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Sponsored by: |
NeoVista |
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Information provided by: | NeoVista |
ClinicalTrials.gov Identifier: | NCT00679445 |
The objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.
Condition | Intervention | Phase |
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Wet Age-Related Macular Degeneration |
Device: NeoVista Ophthalmic System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Feasibility Study to Evaluate the Safety And Tolerability of the EPI-RAD90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization (CNV) in Patients With Age-Related Macular Degeneration (AMD) That Have Failed Primary Anti-VEGF Therapy |
Estimated Enrollment: | 20 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Device: NeoVista Ophthalmic System A single procedure using the NeoVista Ophthalmic System plus an injection of Lucentis.
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Device: NeoVista Ophthalmic System
A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.
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Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy 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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Contact | clinicaltrials@neovistainc.com |
United States, Massachusetts | |
Ophthalmic Consultants of Boston | Recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, Texas | |
Medical Center Ophthalmology Associates | Recruiting |
San Antonio, Texas, United States, 78240 |
Principal Investigator: | Jeffrey S Heier, MD | Ophthalmic Consultants of Boston |
Study Director: | Jeffrey A Nau, MMS | NeoVista, Inc |
Principal Investigator: | Michael Singer, MD | Medical Center Ophthalmology Associates |
Responsible Party: | NeoVista Incorporated ( Jeffrey Nau, MMS (Director, Clinical Affairs) ) |
Study ID Numbers: | NVI-006 |
Study First Received: | May 14, 2008 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00679445 |
Health Authority: | United States: Food and Drug Administration |
Macular Degeneration AMD Wet Age-related macular degeneration |
Metaplasia Eye Diseases Choroid Diseases Retinal Degeneration Macular Degeneration |
Bevacizumab Neovascularization, Pathologic Retinal Diseases Retinal degeneration Choroidal Neovascularization |
Uveal Diseases Pathologic Processes |