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OpenTrials
Completed

NCT Number: NCT00493064

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Palo Alto Medical Foundation Department of Ophthalmology

Palo Alto, California, 94301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotinic acid

Drug

topical eye drops

Other names: Niacin

Prednisolone Acetate

Drug

topical eye drops

Primary outcomes

  1. 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.

    Time frame: one year

    improvement with combination of niacin and topical prednisolone acetate

Secondary outcomes

  1. A Decrease in the Thickness of the Retina

    Time frame: one year

    data not available

Sponsors and collaborators

Lead sponsor

Palo Alto Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2007
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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