Phase 3
N=63
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00493064 ↗Enrolled (actual)
63
Serious AEs
—
Results posted
Dec 2018
Primary outcome: 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 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nicotinic acid (Drug); Prednisolone acetate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Palo Alto Medical Foundation
- Primary completion
- Oct 2016
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 |
— | — |
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.
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.