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

NCT ID: NCT00493064

Last Updated: 2018-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinal Vein Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective active treatment

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Group Type EXPERIMENTAL

Nicotinic acid

Intervention Type DRUG

topical eye drops

Prednisolone acetate

Intervention Type DRUG

topical eye drops

Interventions

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Nicotinic acid

topical eye drops

Intervention Type DRUG

Prednisolone acetate

topical eye drops

Intervention Type DRUG

Other Intervention Names

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Niacin

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palo Alto Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Gaynon, MD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

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Palo Alto Medical Foundation Department of Ophthalmology

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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06-21

Identifier Type: -

Identifier Source: org_study_id