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

NCT00493064 | Completed Phase 2 Results

• 1 other identifier: 06-21
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A Decrease in the Thickness of the Retina

  one year

Study Arms (1)

Prospective active treatment

EXPERIMENTAL

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Drug: Nicotinic acid; Drug: Prednisolone acetate

Interventions

Nicotinic acid DRUG

topical eye drops

Also known as: Niacin

Prospective active treatment

Prednisolone acetate DRUG

topical eye drops

Prospective active treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palo Alto Medical Foundation: lead

Study Sites (1)

Palo Alto Medical Foundation Department of Ophthalmology

Palo Alto, California, 94301, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Niacin; prednisolone acetate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Renee Kaneshiro, study coordinator
• Organization: PaloAltoMF

kaneshr@pamf.org

650-853-4744

Study Officials

• Michael Gaynon, MD

  Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: October 1, 2006
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 21, 2018
• Results First Posted: December 21, 2018

Record last verified: 2018-12

Locations

US (1)