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

Phase 2

Completed

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: Nicotinic acid; Drug: Prednisolone acetate

• Registration Number: NCT00493064
• Lead Sponsor: Palo Alto Medical Foundation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-27
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2018-08-27
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Results First Posted: 2018-12-21
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective active treatment	Nicotinic acid	Niacin 500mg TID PO for treatment of retinal vein occlusions.
Prospective active treatment	Prednisolone acetate	Niacin 500mg TID PO for treatment of retinal vein occlusions.

Primary Outcome Measures

Name	Time	Method
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.	one year	improvement with combination of niacin and topical prednisolone acetate

Secondary Outcome Measures

Name	Time	Method
A Decrease in the Thickness of the Retina	one year	data not available

Trial Locations

Locations (1)

Palo Alto Medical Foundation Department of Ophthalmology; 🇺🇸 Palo Alto, California, United States