We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500045
Recruitment Status : Terminated (The PI retired/left the institution. Efforts were made to contact the PI but were unsuccessful.)
First Posted : July 12, 2007
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Palo Alto Medical Foundation

Tracking Information
First Submitted Date  ICMJE July 10, 2007
First Posted Date  ICMJE July 12, 2007
Results First Submitted Date  ICMJE October 21, 2019
Results First Posted Date  ICMJE November 13, 2019
Last Update Posted Date November 13, 2019
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
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. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
An improvement in vision in the the treatment patients, as measured by an increase of 15 letters on the EDTRS Vision chart. [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
A Decrease in the Thickness of the Retina [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
A decrease in the thickness of the retina [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions
Official Title  ICMJE "Retrospective Study of Niacin (as a Vasodilator), Combined With a Topical Steroid (for Macular Edema), For CRVO, HRVO, BRVO."
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Central Retinal Vein Occlusion
  • Branch Retinal Vein Occlusion
Intervention  ICMJE Drug: nicotinic acid
niacin 1500 mg po qd
Other Name: niacin
Study Arms  ICMJE Experimental: Treatment
Oral niacin
Intervention: Drug: nicotinic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 6, 2017)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2007)
45
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00500045
Other Study ID Numbers  ICMJE PAMF 08-51
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Palo Alto Medical Foundation
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Palo Alto Medical Foundation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Gaynon, MD Palo Alto Medical Foundation
PRS Account Palo Alto Medical Foundation
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP