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

Retinal Vein Occlusion Clinical Trial

Official title:

Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493064
• Other study ID #: 06-21
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2006
• Est. completion date: October 2016

Study information

• Verified date: December 2018
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• Nicotinic acid
topical eye drops
• Prednisolone acetate
topical eye drops

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation Department of Ophthalmology	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Secondary	A Decrease in the Thickness of the Retina	data not available	one year