Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions

• Sponsor: Palo Alto Medical Foundation (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00500045
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 116
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion	Drug: nicotinic acid	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: "Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For CRVO, HRVO, BRVO."
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Oral niacin	Drug: nicotinic acid; niacin 1500 mg po qd; Other Names: niacin

Outcome Measures

Primary Outcome Measures

1. 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. [one year]

   0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.

Secondary Outcome Measures

1. A Decrease in the Thickness of the Retina [one year]

   0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Medical Foundation Department of Ophthalmology	Palo Alto	California	United States	94301

Sponsors and Collaborators

• Palo Alto Medical Foundation

Investigators

• Principal Investigator: Michael Gaynon, MD, Palo Alto Medical Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Palo Alto Medical Foundation
• ClinicalTrials.gov Identifier: NCT00500045
• Other Study ID Numbers: PAMF 08-51
• First Posted: Jul 12, 2007
• Last Update Posted: Nov 13, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Palo Alto Medical Foundation: CRVO; HRVO; BRVO
• Additional relevant MeSH terms: Retinal Vein Occlusion; Niacin; Nicotinic Acids; Niacinamide

Study Results

Participant Flow

Arm/Group Title	Treatment
Arm/Group Description	Oral niacin nicotinic acid: niacin 1500 mg po qd 0 participants started and completed in each arm/group. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Oral niacin nicotinic acid: niacin 1500 mg po qd 0 participants analyzed for the overall number of baseline participants. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	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.
Description	0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.

Arm/Group Title	Treatment
Arm/Group Description	Oral niacin nicotinic acid: niacin 1500 mg po qd 0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Measure Participants	0

2. Secondary Outcome

Title	A Decrease in the Thickness of the Retina
Description	0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.

Arm/Group Title	Treatment
Arm/Group Description	Oral niacin nicotinic acid: niacin 1500 mg po qd 0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	0 participants at risk (for each arm/group in both serious and other adverse events). The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
Arm/Group Title	Adverse Events
Arm/Group Description	0 participants at risk (for each arm/group in both serious and other adverse events). The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.
All Cause Mortality
	Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

The PI has retired and left the institution. Efforts were not successful in obtaining data for the study results.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.