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

Information source: Palo Alto Medical Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Vein Occlusion

Intervention: Nicotinic acid (Drug); Prednisolone acetate (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Palo Alto Medical Foundation

Official(s) and/or principal investigator(s):
Michael Gaynon, MD, Principal Investigator, Affiliation: Palo Alto Medical Foundation

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: An improvement in vision in the treatment patients, as measured by an increase of 15 letters on the EDTRS Vision chart.

Secondary outcome: A decrease in the thickness of the retina

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Palo Alto Medical Foundation Department of Ophthalmology, Palo Alto, California 94301, United States
Additional Information

Starting date: October 2006
Last updated: July 21, 2011

Page last updated: August 23, 2015

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