Overview

This trial is active, not recruiting.

Condition retinal vein occlusion
Treatments nicotinic acid, prednisolone acetate
Phase phase 2/phase 3
Sponsor Palo Alto Medical Foundation
Start date October 2006
End date December 2016
Trial size 68 participants
Trial identifier NCT00493064, 06-21

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Niacin 500mg TID PO for treatment of retinal vein occlusions.
nicotinic acid Niacin
topical eye drops
prednisolone acetate
topical eye drops

Primary Outcomes

Measure
An improvement in vision in the treatment patients, as measured by an increase of 15 letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision chart.
time frame: one year

Secondary Outcomes

Measure
A decrease in the thickness of the retina
time frame: one year

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO
Principal investigator Michael Gaynon, MD
Description The aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vein occlusion that are being studied include central (CRVO), hemi-retinal (HRVO), and branch (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide)a B-vitamin, has lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the Niacin is taking effect.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Palo Alto Medical Foundation.