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

NCT00500045 | Terminated Phase 2 Results

• 1 other identifier: PAMF 08-51
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion

Keywords

CRVO; HRVO; BRVO

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (1)

• A Decrease in the Thickness of the Retina

  one year

Study Arms (1)

Treatment

EXPERIMENTAL

Oral niacin

Drug: nicotinic acid

Interventions

nicotinic acid DRUG

niacin 1500 mg po qd

Also known as: niacin

Treatment

Eligibility Criteria

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

You may qualify if:

• Patients must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.

You may not qualify if:

• Patients with active gout or high levels of uric acid.

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

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

Limitations and Caveats

The PI has retired and left the institution. Efforts were not successful in obtaining data for the study results.

Results Point of Contact

• Title: Renee Kaneshiro
• Organization: Palo Alto Medical Foundation

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: July 10, 2007
• First Posted: July 12, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Locations

US (1)