Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for 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:
NCT00500045
First received: July 10, 2007
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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 vien occlusion that are being studied include central (CVRO), 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.


Condition Intervention Phase
Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Drug: nicotinic acid
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: "Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For 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 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: 45
Study Start Date: February 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Oral niacin
Drug: nicotinic acid
niacin 1500 mg po qd
Other Name: niacin

Detailed Description:

A spontaneous improvement was noted in some patients who were experiencing deteriorating retinal vein occlusions. A chart review and questioning of the patients revealed that the addition of Niacin by the Internist seemed to be the factor that was bringing about the vision improvement.

The Niacin has vasodilating properties, and it is postulated that as the Niacin dilates the retinal vessels, it will encourage earlier collateral vessel formation that will bypass the venous obstruction, and restore venous outflow. The prednisolone steroid eye drops will hopefully reduce the macular edema in the eye.

This is a retrospective study conducted by chart review of up to 45 patients who have undergone treatment with 1500 mg per day of oral Niacin (Nicotinic acid) with or without topical steroid eye drops, Prednisolone acetate (Pred Forte) for the treatment of retinal vein occlusion central (CRVO), hemi-retinal (HRVO), branch (BRVO). The retrospective chart review of patients seen by Dr. Michael Gaynon will go back to 1998 and will continue through the present time. All patients with vision impairment caused by deteriorating retinal vein occlusion, and who were or will be prescribed the Niacin with or without Pred Forte treatment will be included.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.

Exclusion Criteria:

  • Patients with active gout or high levels of uric acid.
  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: NCT00500045

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: NCT00500045     History of Changes
Other Study ID Numbers: PAMF 08-51
Study First Received: July 10, 2007
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Medical Foundation:
CRVO
HRVO
BRVO

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Niacin
Nicotinic Acids
Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014