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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Palo Alto Medical Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Palo Alto Medical Foundation
ClinicalTrials.gov Identifier:
NCT00493064
First received: June 25, 2007
Last updated: July 21, 2011
Last verified: July 2011
  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: Allocation: Non-Randomized
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 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 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Gaynon, MD, Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00493064     History of Changes
Other Study ID Numbers: 06-21
Study First Received: June 25, 2007
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Niacin
Nicotinic Acids
Niacinamide
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on September 14, 2014