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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Intervention Drug: nicotinic acid
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide 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
Arm/Group Title Treatment
Hide 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 Number of Baseline Participants 0
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title A Decrease in the Thickness of the Retina
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
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
Hide 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 (%)
Total   0/0 
Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events
Affected / at Risk (%)
Total   0/0 
The PI has retired and left the institution. Efforts were not successful in obtaining data for the study results.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Renee Kaneshiro
Organization: Palo Alto Medical Foundation
Phone: 650-853-4744
EMail: kaneshr@pamf.org
Layout table for additonal information
Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00500045    
Other Study ID Numbers: PAMF 08-51
First Submitted: July 10, 2007
First Posted: July 12, 2007
Results First Submitted: October 21, 2019
Results First Posted: November 13, 2019
Last Update Posted: November 13, 2019