- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00493064
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
December 18, 2018 updated by: Palo Alto Medical Foundation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Department of Ophthalmology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prospective active treatment
Niacin 500mg TID PO for treatment of retinal vein occlusions.
|
topical eye drops
Other Names:
topical eye drops
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
Time Frame: one year
|
improvement with combination of niacin and topical prednisolone acetate
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A Decrease in the Thickness of the Retina
Time Frame: one year
|
data not available
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Gaynon, MD, Palo Alto Medical Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
June 25, 2007
First Submitted That Met QC Criteria
June 25, 2007
First Posted (Estimate)
June 27, 2007
Study Record Updates
Last Update Posted (Actual)
December 21, 2018
Last Update Submitted That Met QC Criteria
December 18, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antimetabolites
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Nicotinic Acids
- Niacinamide
- Niacin
Other Study ID Numbers
- 06-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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