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NCT01972438 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Controlled, Double-Masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-Host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01972438 is a Phase 2 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 18 participants.
The verdict
NCT01972438, a Phase 2 study, was terminated before completion, sponsored by National Eye Institute (NEI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Some eye diseases can be helped by eye drops made from a person's own blood. These eye drops are called autologous serum eye drops, or ASEDs. ASEDs have been studied in only a few people with graft vs. host disease (GVHD) affecting the eye and were found to be helpful with few side effects. The purpose of this study was to determine whether ASEDs are safe and more effective than control (normal saline) and can help with eye symptoms in people with severe chronic eye GVHD. Each participant in this study was to have blood drawn to prepare ASEDs specifically for the participant. Each participant was scheduled to receive ASEDs for 3 months and placebo eye drops (salt water) for 3 months. Participants did not know when they were receiving the ASEDs and when they were receiving placebo eye drops.
Interventions
- DRUG Saline
- DRUG ASEDs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01972438
The ClinicalTrials.gov registry entry for NCT01972438 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 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 2 interventions - of which Saline is the first listed.
NCT01972438 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01972438 about?
NCT01972438 is a clinical study titled "A Randomized, Controlled, Double-Masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-Host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients". Some eye diseases can be helped by eye drops made from a person's own blood. These eye drops are called autologous serum eye drops, or ASEDs. ASEDs have been studied in only a few people with graft vs. host disease (GVHD) affecting the eye and were found to be helpful with few side effects. The pur...
What is the current status of trial NCT01972438?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2013-11. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01972438?
The interventions under investigation include: Saline (DRUG), ASEDs (DRUG).
Who is sponsoring clinical trial NCT01972438?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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