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| Sponsor: | Theragenics Corporation |
|---|---|
| Information provided by: | Theragenics Corporation |
| ClinicalTrials.gov Identifier: | NCT00100087 |
Purpose
The study will investigate the safety and feasibility of using the TheraSight(TM) Brachytherapy System for treatment of wet age-related macular degeneration (AMD).
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration Choroidal Neovascularization |
Device: Ocular Brachytherapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Dose Comparison Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Safety and Feasibility Study of the TheraSight(TM) Ocular Brachytherapy System for Treatment of Age-Related Macular Degeneration |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2004 |
This is a multi-center randomized study of three doses of radiation (assigned 1:1:1) delivered by the TheraSight(TM) Brachytherapy System in participants with choroidal neovascularization (CNV) secondary to wet (exudative) AMD. Each participant receives a single dose of radiation delivered by one-time only brachytherapy. Participants are followed for three years after the radiation treatment.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active primary or recurrent subfoveal CNV secondary to AMD with minimally classic or occult lesion, where an active lesion is defined as one or more of the following:
a) An increase > 10% in lesion size (greatest linear dimension) on screening fluorescein angiography compared to previous fluorescein angiography no more than 180 days preceding screening visit
Exclusion Criteria:
Contacts and Locations| Contact: Theragenics Corporation | 1-877-960-1234 |
| United States, Georgia | |
| Theragenics Clinical Site | Recruiting |
| Atlanta, Georgia, United States | |
| Theragenics Clinical Site | Recruiting |
| Augusta, Georgia, United States | |
| United States, Indiana | |
| Theragenics Clinical Site | Recruiting |
| Indianapolis, Indiana, United States | |
| United States, Massachusetts | |
| Theragenics Clinical Site | Recruiting |
| Boston, Massachusetts, United States | |
| United States, New Jersey | |
| Theragenics Clinical Site | Recruiting |
| Newark, New Jersey, United States | |
| United States, North Carolina | |
| Theragenics Clinical Site | Recruiting |
| Raleigh / Durham, North Carolina, United States | |
More Information
| ClinicalTrials.gov Identifier: | NCT00100087 History of Changes |
| Other Study ID Numbers: | NPD-07-01 |
| Study First Received: | December 22, 2004 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
macular degeneration brachytherapy choroidal neovascularization retinal degeneration retinal diseases |
|
Macular Degeneration Neovascularization, Pathologic Choroidal Neovascularization Retinal Degeneration Retinal Diseases |
Eye Diseases Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases |