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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 is ongoing, but not recruiting participants.
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
History of Changes

June 25, 2007
July 21, 2011
October 2006
December 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00493064 on ClinicalTrials.gov Archive Site
A decrease in the thickness of the retina [ Time Frame: one year ] [ Designated as safety issue: Yes ]
A decrease in the thickness of the retina [ Time Frame: one year ]
 
 
 
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinal Vein Occlusion
  • Drug: Nicotinic acid
    topical eye drops
    Other Name: Niacin
  • Drug: Prednisolone acetate
    topical eye drops
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00493064
06-21
No
Michael Gaynon, MD, Palo Alto Medical Foundation
Palo Alto Medical Foundation
 
Principal Investigator: Michael Gaynon, MD Palo Alto Medical Foundation
Palo Alto Medical Foundation
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP