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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Michael Gaynon M.D., Palo Alto Medical Foundation Identifier:
First received: June 25, 2007
Last updated: October 21, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Retinal Vein Occlusion
Drug: Nicotinic acid
Drug: Prednisolone acetate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO

Resource links provided by NLM:

Further study details as provided by Palo Alto Medical Foundation:

Primary Outcome Measures:
  • An improvement in vision in the treatment patients, as measured by an increase of 15 letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision chart. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A decrease in the thickness of the retina [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 68
Study Start Date: October 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prospective active treatment
Niacin 500mg TID PO for treatment of retinal vein occlusions.
Drug: Nicotinic acid
topical eye drops
Other Name: Niacin
Drug: Prednisolone acetate
topical eye drops

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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00493064

United States, California
Palo Alto Medical Foundation Department of Ophthalmology
Palo Alto, California, United States, 94301
Sponsors and Collaborators
Palo Alto Medical Foundation
Principal Investigator: Michael Gaynon, MD Palo Alto Medical Foundation
  More Information

No publications provided

Responsible Party: Michael Gaynon M.D., Principal Investigator, Palo Alto Medical Foundation Identifier: NCT00493064     History of Changes
Other Study ID Numbers: 06-21
Study First Received: June 25, 2007
Last Updated: October 21, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Retinal Diseases
Vascular Diseases
Venous Thrombosis
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Nicotinic Acids
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Gastrointestinal Agents
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on November 30, 2015