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

Primary Purpose

Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nicotinic acid
Sponsored by
Palo Alto Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring CRVO, HRVO, BRVO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Palo Alto Medical Foundation Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Oral niacin

Outcomes

Primary Outcome Measures

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.
0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.

Secondary Outcome Measures

A Decrease in the Thickness of the Retina
0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.

Full Information

First Posted
July 10, 2007
Last Updated
October 21, 2019
Sponsor
Palo Alto Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00500045
Brief Title
Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions
Official Title
"Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For CRVO, HRVO, BRVO."
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
The PI retired/left the institution. Efforts were made to contact the PI but were unsuccessful.
Study Start Date
February 2007 (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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion
Keywords
CRVO, HRVO, BRVO

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
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Oral niacin
Intervention Type
Drug
Intervention Name(s)
nicotinic acid
Other Intervention Name(s)
niacin
Intervention Description
niacin 1500 mg po qd
Primary Outcome Measure Information:
Title
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.
Description
0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Time Frame
one year
Secondary Outcome Measure Information:
Title
A Decrease in the Thickness of the Retina
Description
0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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

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

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