Phase 3
Completed N=63
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
Source: ClinicalTrials.gov NCT00493064 ↗Enrolled (actual)
63
Serious AEs
—
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart. — 63 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart. |
63 | — |
| SECONDARY A Decrease in the Thickness of the Retina |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be able to understand the study procedures, agree to participate, and give written consent.
- Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.
- Patients must be able to follow the study medication regimen.
- Patients must agree to return for the once monthly eye exams.
- Patients must agree to have liver function tests performed on a regular basis.
- Patients must agree to have regular appointments with their Internist on an established basis.
Exclusion Criteria
- Patients with active Gout, or high levels of Uric
- Patients may not be pregnant or lactating.
- The Principal Investigator reserves the right to exclude any patient who he feels will not make a good candidate.
Data sourced from ClinicalTrials.gov (NCT00493064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.