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

Sutter Health

Status and phase

Completed

Phase 3

Phase 2

Conditions

Retinal Vein Occlusion

Treatments

Drug: Nicotinic acid

Drug: Prednisolone acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT00493064

06-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Volunteers

No Healthy Volunteers

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.