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NCT00043680 · ClinicalTrials.gov registry record · Phase 2
Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00043680 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 60 participants.
The verdict
NCT00043680, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can help stabilize or improve vision in patients with age-related macular degeneration (AMD) who are receiving photodynamic therapy, or PDT (also called cold laser treatment). 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 new blood vessels in the choroid-a thin, pigmented vascular layer of the eye 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, the treatment usually does not cause vision to improve, and it has only a temporary effect, requiring several treatments over 2 years. Furthermore, PDT does not work in all patients and may actually cause some swelling and re-growth of blood vessels. Celecoxib is an anti-inflammatory drug that, in animal studies, has prevented the growth of abnormal blood vessels associated with tumors and with injury to the cornea. Thus, the drug might reduce swelling and prevent vessel re-growth in AMD, enhancing the effectiveness of PDT. Patients 55 years of age and older with AMD and visual acuity of 20/20 to 20/200 may be eligible for this study. Participants will be randomly assigned to take either celecoxib or a placebo (a look-alike pill with no active drug) twice a day and undergo the various tests and procedures detailed below. Not every examination will be done at every visit, but all may be required at one visit. * Medical history and physical examination * Blood drawing: A blood sample is drawn from an arm vein to evaluate liver and kidney function * Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined * Photography: Photographs of the eye are taken using a spe
Interventions
- DRUG Celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-08 |
| Est. Completion | 2005-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00043680
The ClinicalTrials.gov registry entry for NCT00043680 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Celecoxib is the first listed.
NCT00043680 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00043680 about?
NCT00043680 is a clinical study titled "Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy". This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can help stabilize or improve vision in patients with age-related macular degeneration (AMD) who are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is the part of the retina...
What is the current status of trial NCT00043680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-08. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00043680?
The interventions under investigation include: Celecoxib (DRUG).
Who is sponsoring clinical trial NCT00043680?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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