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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493064
First Posted: June 27, 2007
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Palo Alto Medical Foundation
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • A decrease in the thickness of the retina [ Time Frame: one year ]

Enrollment: 63
Study Start Date: October 2006
Study Completion Date: October 2016
Primary Completion Date: October 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493064


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

Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00493064     History of Changes
Other Study ID Numbers: 06-21
First Submitted: June 25, 2007
First Posted: June 27, 2007
Last Update Posted: April 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Ophthalmic Solutions
Tetrahydrozoline
Niacin
Niacinamide
Nicotinic Acids
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents