Clinical trial NCT00500045: Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions
Official title: "Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For CRVO, HRVO, BRVO."
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Keywords: CRVO
HRVO
BRVO
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
First posted: 2007-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: one year
Secondary outcomes:
measure: A Decrease in the Thickness of the Retina
timeFrame: one year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Department of Ophthalmology
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Michael Gaynon, MD
role: PRINCIPAL_INVESTIGATOR
References: