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

October 21, 2019 updated by: Palo Alto Medical Foundation

"Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For CRVO, HRVO, BRVO."

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

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

  • United States
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
Oral niacin
Drug: nicotinic acid
niacin 1500 mg po qd
Other Names:
  • niacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Decrease in the Thickness of the Retina
Time Frame: one year
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Medical Foundation

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

February 1, 2007

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAMF 08-51

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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