To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
Primary Purpose
Retinal Vein Occlusion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nicotinic acid
Prednisolone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion
Eligibility Criteria
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.
Sites / Locations
- Palo Alto Medical Foundation Department of Ophthalmology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prospective active treatment
Arm Description
Niacin 500mg TID PO for treatment of retinal vein occlusions.
Outcomes
Primary Outcome Measures
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.
improvement with combination of niacin and topical prednisolone acetate
Secondary Outcome Measures
A Decrease in the Thickness of the Retina
data not available
Full Information
NCT ID
NCT00493064
First Posted
June 25, 2007
Last Updated
December 18, 2018
Sponsor
Palo Alto Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00493064
Brief Title
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
Official Title
Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Medical Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective active treatment
Arm Type
Experimental
Arm Description
Niacin 500mg TID PO for treatment of retinal vein occlusions.
Intervention Type
Drug
Intervention Name(s)
Nicotinic acid
Other Intervention Name(s)
Niacin
Intervention Description
topical eye drops
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate
Intervention Description
topical eye drops
Primary Outcome Measure Information:
Title
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.
Description
improvement with combination of niacin and topical prednisolone acetate
Time Frame
one year
Secondary Outcome Measure Information:
Title
A Decrease in the Thickness of the Retina
Description
data not available
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gaynon, MD
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation Department of Ophthalmology
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
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