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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Nicotinic acid
* Drug: Prednisolone acetate


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective active treatment<br>Niacin 500mg TID PO for treatment of retinal vein occlusions. | Drug: Nicotinic acid<br>* topical eye drops<br>* Other names: Niacin;Drug: Prednisolone acetate<br>* topical eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | improvement with combination of niacin and topical prednisolone acetate | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Decrease in the Thickness of the Retina | data not available | one year |