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Trial record 81 of 81 for:    CRVO - Central Retinal Vein Occlusion

To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat 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: NCT00493064
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Palo Alto Medical Foundation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Retinal Vein Occlusion
Interventions Drug: Nicotinic acid
Drug: Prednisolone acetate
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prospective Active Treatment
Hide Arm/Group Description

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Nicotinic acid: topical eye drops

Prednisolone acetate: topical eye drops

Period Title: Overall Study
Started 63
Completed 52
Not Completed 11
Arm/Group Title Prospective Active Treatment
Hide Arm/Group Description

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Nicotinic acid: topical eye drops

Prednisolone acetate: topical eye drops

Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  22.2%
>=65 years
49
  77.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
26
  41.3%
Male
37
  58.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
 100.0%
1.Primary Outcome
Title 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.
Hide Description improvement with combination of niacin and topical prednisolone acetate
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prospective Active Treatment
Hide Arm/Group Description:

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Nicotinic acid: topical eye drops

Prednisolone acetate: topical eye drops

Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
63
 100.0%
2.Secondary Outcome
Title A Decrease in the Thickness of the Retina
Hide Description data not available
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Prospective Active Treatment
Hide Arm/Group Description:

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Nicotinic acid: topical eye drops

Prednisolone acetate: topical eye drops

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Prospective Active Treatment
Hide Arm/Group Description

Niacin 500mg TID PO for treatment of retinal vein occlusions.

Nicotinic acid: topical eye drops

Prednisolone acetate: topical eye drops

All-Cause Mortality
Prospective Active Treatment
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Prospective Active Treatment
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prospective Active Treatment
Affected / at Risk (%)
Total   0/0 
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
Name/Title: Renee Kaneshiro, study coordinator
Organization: PaloAltoMF
Phone: 650-853-4744
Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00493064     History of Changes
Other Study ID Numbers: 06-21
First Submitted: June 25, 2007
First Posted: June 27, 2007
Results First Submitted: August 27, 2018
Results First Posted: December 21, 2018
Last Update Posted: December 21, 2018