To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:12/23/2018
Start Date:October 2006
End Date:October 2016

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Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO

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.

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.

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.
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