Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions
Information source: Palo Alto Medical Foundation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion
Intervention: nicotinic acid (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Palo Alto Medical Foundation Official(s) and/or principal investigator(s): Michael Gaynon, MD, Principal Investigator, Affiliation: Palo Alto Medical Foundation
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.
Clinical Details
Official title: "Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For CRVO, HRVO, BRVO."
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: An improvement in vision in the the treatment patients, as measured by an increase of 15 letters on the EDTRS Vision chart.
Secondary outcome: A decrease in the thickness of the retina
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Palo Alto Medical Foundation Department of Ophthalmology, Palo Alto, California 94301, United States
Additional Information
Starting date: February 2007
Last updated: July 21, 2011
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