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NCT03981549 · ClinicalTrials.gov registry record · Phase 1
Treatment of Central Retinal Vein Occlusion Using Stem Cells Study
A Phase 1 study of Central Retinal Vein Occlusion, sponsored by The Emmes Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03981549: Completed Phase 1 study of Central Retinal Vein Occlusion, sponsored by The Emmes Company.
NCT03981549 is a Phase 1 study of Central Retinal Vein Occlusion that has completed, run by The Emmes Company. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03981549, a Phase 1 study of Central Retinal Vein Occlusion, has completed, sponsored by The Emmes Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 1 year.
Primary Outcome
The primary safety outcome will be assessed at month 6. Adverse events (AE) that occur during the first 6 months of the trial will be broken down by whether the AE occurred following the sham or cellular treatment to assess differences in the adverse event experience between the cellular and sham therapies.
Conditions Studied
Interventions
- BIOLOGICAL Autologous Bone Marrow CD34+ Stem Cells
- BIOLOGICAL Sham Therapy
Study Locations (1)
California
- Department of Ophthalmology & Vision Science, University of California Davis Eye Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 1 |
What the finished NCT03981549 record still lists
NCT03981549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Central Retinal Vein Occlusion appearing as the primary indexed condition, and to 2 interventions - of which Autologous Bone Marrow CD34+ Stem Cells is the first listed.
NCT03981549 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03981549 about?
NCT03981549 is a clinical study titled "Treatment of Central Retinal Vein Occlusion Using Stem Cells Study". This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, whi...
What is the current status of trial NCT03981549?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-10-22. Estimated completion is 2023-11-09.
What conditions does trial NCT03981549 study?
This clinical trial studies the following conditions: Central Retinal Vein Occlusion.
What interventions are being tested in trial NCT03981549?
The interventions under investigation include: Autologous Bone Marrow CD34+ Stem Cells (BIOLOGICAL), Sham Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT03981549?
This trial is sponsored by The Emmes Company, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03981549 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03981549's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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