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NCT00102583 · ClinicalTrials.gov registry record · Phase 1
Cyclosporine Implant for Ocular Graft-Versus-Host Disease
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00102583 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 4 participants.
The verdict
NCT00102583, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Graft-vs.-Host Disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (SCT) commonly affecting the skin, liver, gastrointestinal tract, and eye. The most common clinical manifestations of ocular GVHD generally result from involvement of the lacrimal gland and the conjunctiva. Lacrimal gland involvement can lead to aqueous tear deficiency resulting in severe keratoconjunctivitis sicca (KCS) which can significantly increase the morbidity of patients with chronic GVHD. Systemic immunosuppressants such as cyclosporine (CsA) can be effective for treating ocular GVHD including lacrimal gland dysfunction. However, systemic immunosuppression is not generally prescribed for patients whose sole manifestation of GVHD is ocular complications as it may negate the overall graft-vs.-tumor effect and decrease patient survival. Topical CsA and corticosteroids are generally not effective for treating aqueous tear deficiency possible due to epithelial barriers preventing penetration of the drugs to the lacrimal gland. A sustained-release subconjunctival CsA implant was developed to bypass these epithelial barriers and significantly increase the CsA concentrations in the lacrimal gland to treat aqueous tear deficiency related to GVHD. The objective of this randomized pilot study is to investigate the safety and potential efficacy of a CsA implant in patients with lacrimal gland involvement and aqueous tear deficiency related to GVHD. Safety will be evaluated in terms of adverse events related to the implant. Efficacy will be evaluated by changes in Schirmer tear test (with anesthesia). Secondary efficacy evaluation will include changes in corneal and conjunctival staining grades, best-corrected visual acuity (BCVA), the Ocular Surface Disease Index (OSDI), changes in conjunctival GVHD grades, tear break-up time and meibomian gland dysfunction. Patients with active systemic GVHD with aqueous tear deficiency associated with lacrimal gland dysfunc
Interventions
- DRUG Subconjunctival Cyclosporine Implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2004-10-14 |
| Est. Completion | 2011-03-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00102583
The ClinicalTrials.gov registry entry for NCT00102583 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 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 Subconjunctival Cyclosporine Implant is the first listed.
NCT00102583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00102583 about?
NCT00102583 is a clinical study titled "Cyclosporine Implant for Ocular Graft-Versus-Host Disease". Graft-vs.-Host Disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (SCT) commonly affecting the skin, liver, gastrointestinal tract, and eye. The most common clinical manifestations of ocular GVHD generally result from involvement of the lacrimal gland and t...
What is the current status of trial NCT00102583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2004-10-14. Estimated completion is 2011-03-15.
What interventions are being tested in trial NCT00102583?
The interventions under investigation include: Subconjunctival Cyclosporine Implant (DRUG).
Who is sponsoring clinical trial NCT00102583?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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