A Phase 2/3 interventional study of Nicotinic acid and Prednisolone acetate in Retinal Vein Occlusion, sponsored by Palo Alto Medical Foundation. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-12-21.
Sponsored by Palo Alto Medical Foundation · Phase 2/3, Interventional, and Treatment
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.
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.
291 studies on the registry are indexed under Retinal Vein Occlusion; 29 are open to participants now.
This study's enrollment of 63 is above the median of 49 across 217 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →Palo Alto Medical Foundation is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Niacin 500mg TID PO for treatment of retinal vein occlusions.
Drug: Nicotinic acid · Drug: Prednisolone acetate
topical eye drops
Also known as: Niacin
topical eye drops
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
A Decrease in the Thickness of the Retina
data not available
Time frame: one year
| Milestone | Prospective Active Treatment |
|---|---|
| Started | 63 |
| Completed | 52 |
| Not completed | 11 |
improvement with combination of niacin and topical prednisolone acetate
| 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 |
data not available
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Active Treatment | — | — | — |
| Age, Categorical(Participants) | Prospective Active Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 49 |
| Sex: Female, Male(Participants) | Prospective Active Treatment |
|---|---|
| Female | 26 |
| Male | 37 |
| Region of Enrollment(Participants) | Prospective Active Treatment |
|---|---|
| United States | 63 |
The record gives a start of Oct 2006, a primary completion of Oct 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2018, 2 years 2 months after primary completion.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Niacin
Palo Alto Medical Foundation