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NCT00100009 · ClinicalTrials.gov registry record · Phase 3
Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration
A Phase 3 study of Macular Degeneration, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT00100009 is a Phase 3 study of Macular Degeneration that has completed, run by National Eye Institute (NEI). The registered enrollment target is 30 participants, below the 178-participant average among 26 other Macular Degeneration trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT00100009, a Phase 3 study of Macular Degeneration, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will test the safety and effectiveness of combining a laser treatment called photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone acetonide for treating age-related macular degeneration (AMD). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal blood vessels behind the retina that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss; however, it has only a temporary effect and does not work in all patients. Furthermore, it may actually cause some swelling and re-growth of blood vessels. Triamcinolone acetonide can help lessen swelling and scarring. Patients 50 years of age and older with AMD may be eligible for this study. Candidates are screened with a medical history, medical evaluation, and eye examinations (see below). Participants are randomly assigned to one of three treatment groups: 1) PDT plus 1 mg TAC-PF; 2) PDT plus 4 mg TAC-PF; or 3) PDT plus sham injection (a syringe with no needle is pressed against the eye). Treatments are given the day the patient enrolls in the study and then every 3 months for 2 years, as long as the therapy is thought beneficial. Patients who must discontinue TAC-PF injections may still be treated with PDT if medically necessary. In addition to treatment, patients undergo the following tests and procedures: * Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined. * Fundus photography: Photographs of the back of the eye are taken using a special camera with a bright flash. * Lens photography: Photographs of the lens are taken to look for development of cataracts. * Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood
Conditions Studied
Interventions
- DRUG Triamcinolone Acetonide
- DRUG TAC-PF
Study Locations (20)
Florida
- Bascom Palmer Eye Institute - Miami
- Central Florida Retina (CFROL) - Orlando
- Retina Associates of Florida - Tampa
Maryland
- Elman Retina Group, P.A. - Baltimore (ERGBM) - Baltimore
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
- Elman Retina Group, P.A. - Pikesville (ERGPM) - Pikesville
Oregon
- Casey Eye Institute-Portland, OR (CEIPO) - Portland
- Retina Northwest (RNWPO) - Portland
Tennessee
- Southeastern Retina Associates (SRAKT) - Knoxville
- Vanderbilt University - Nashville
Arizona
- Retina Associates Southwest (RASTA) - Tucson
California
- Doheny Eye Institute - Los Angeles
Indiana
- Midwest Eye Institute - Indianapolis
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-12-09 |
| Est. Completion | 2006-12-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00100009
The ClinicalTrials.gov registry entry for NCT00100009 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 26 other Macular Degeneration trials with a reported enrollment target (83% lower). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Triamcinolone Acetonide is the first listed.
NCT00100009 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Maryland, Oregon.
Frequently Asked Questions
What is clinical trial NCT00100009 about?
NCT00100009 is a clinical study titled "Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration". This study will test the safety and effectiveness of combining a laser treatment called photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone acetonide for treating age-related macular degeneration (AMD). The macula is the part of the retina in the back of the eye t...
What is the current status of trial NCT00100009?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2004-12-09. Estimated completion is 2006-12-20.
What conditions does trial NCT00100009 study?
This clinical trial studies the following conditions: Macular Degeneration.
What interventions are being tested in trial NCT00100009?
The interventions under investigation include: Triamcinolone Acetonide (DRUG), TAC-PF (DRUG).
Who is sponsoring clinical trial NCT00100009?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00100009 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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