Retinal Vein Occlusion
Conditions
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.
Detailed 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.
Interventions
DRUGNicotinic acid
topical eye drops
DRUGPrednisolone acetate
topical eye drops
Sponsors
Palo Alto Medical Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | one year | improvement with combination of niacin and topical prednisolone acetate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Decrease in the Thickness of the Retina | one year | data not available |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospective Active Treatment Niacin 500mg TID PO for treatment of retinal vein occlusions.
Nicotinic acid: topical eye drops
Prednisolone acetate: topical eye drops | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | Prospective Active Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 49 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Region of Enrollment United States | 63 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Active Treatment | 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. | 63 Participants |
Secondary
A Decrease in the Thickness of the Retina
data not available
Time frame: one year
Population: Although data for this outcome measure was collected, however, data are not available. The PI is retired and no longer works in the organization. Sincere efforts were made to obtain the data, however, no data are available for this outcome.