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Trial record 43 of 81 for:    CRVO - Central Retinal Vein Occlusion

Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions

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ClinicalTrials.gov Identifier: NCT00500045
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Palo Alto Medical Foundation

Brief Summary:
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 or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Branch Retinal Vein Occlusion Drug: nicotinic acid Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (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."
Study Start Date : February 2007
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Oral niacin
Drug: nicotinic acid
niacin 1500 mg po qd
Other Name: niacin




Primary Outcome Measures :
  1. An improvement in vision in the 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 :
  1. A decrease in the thickness of the retina [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT00500045


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

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Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00500045     History of Changes
Other Study ID Numbers: PAMF 08-51
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Palo Alto Medical Foundation:
CRVO
HRVO
BRVO

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