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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective active treatment | Experimental | Niacin 500mg TID PO for treatment of retinal vein occlusions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinic acid | Drug | topical eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
| Measure | Description | Time Frame |
|---|---|---|
| A Decrease in the Thickness of the Retina | data not available | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gaynon, MD | Palo Alto Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation Department of Ophthalmology | Palo Alto | California | 94301 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Active Treatment | Niacin 500mg TID PO for treatment of retinal vein occlusions. Nicotinic acid: topical eye drops Prednisolone acetate: topical eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Active Treatment | Niacin 500mg TID PO for treatment of retinal vein occlusions. Nicotinic acid: topical eye drops Prednisolone acetate: topical eye drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | one year |
|
|
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No information regarding the Adverse Events is available. The PI is retired and no longer works for the organization. Sincere efforts were made to obtain the data, however, no Adverse Events data are available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Active Treatment | Niacin 500mg TID PO for treatment of retinal vein occlusions. Nicotinic acid: topical eye drops Prednisolone acetate: topical eye drops |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renee Kaneshiro, study coordinator | PaloAltoMF | 650-853-4744 | kaneshr@pamf.org |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Prednisolone acetate | Drug | topical eye drops |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | A Decrease in the Thickness of the Retina | data not available | 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. | Posted | one year |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |