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Topical IL-1-Ra for Treatment of Corneal Neovascularization

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00915590
First received: June 4, 2009
Last updated: May 5, 2017
Last verified: May 2017
Results First Received: October 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Corneal Neovascularization
Interventions: Drug: Placebo
Drug: IL-1Ra

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients in this study were recruited from Mass. Eye and Ear Infirmary from May 2009 - February 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a single site, randomized, double masked, crossover, phase I/II study of topical IL-1Ra (5.0%) in subjects with corneal neovascularization.

Reporting Groups
  Description
Placebo First, Then IL-1Ra

10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.

IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks

IL-1Ra First, Then Placebo

10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo

IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks


Participant Flow:   Overall Study
    Placebo First, Then IL-1Ra   IL-1Ra First, Then Placebo
STARTED   5   5 
COMPLETED   3   4 
NOT COMPLETED   2   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo First, Then IL-1Ra

10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.

IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks

IL-1Ra First, Then Placebo

10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo

IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks

Total Total of all reporting groups

Baseline Measures
   Placebo First, Then IL-1Ra   IL-1Ra First, Then Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  60.0%      1  20.0%      4  40.0% 
>=65 years      2  40.0%      4  80.0%      6  60.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (24)   66  (19)   56  (22) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  40.0%      2  40.0%      4  40.0% 
Male      3  60.0%      3  60.0%      6  60.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   10 


  Outcome Measures
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1.  Primary:   Incidence and Severity of Ocular Adverse Event   [ Time Frame: 64 Weeks ]

2.  Primary:   Extent of Neovascular Area (NA)   [ Time Frame: 64 weeks ]

3.  Primary:   Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels   [ Time Frame: 64 Weeks ]

4.  Primary:   Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels   [ Time Frame: 64 Weeks ]

5.  Secondary:   Best Spectacle-Corrected Visual Acuity (BSCVA)   [ Time Frame: 64 weeks ]

6.  Secondary:   Central Corneal Thickness   [ Time Frame: 64 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Enrollment goal for this study was set at 20 participants (10 for each treatment arm). After an interim analysis, the Principal Investigator decided to terminate the study and stop enrollment.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Reza Dana, MD, MPH, MSc
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-3313
e-mail: Cornea_Research@meei.harvard.edu



Responsible Party: Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00915590     History of Changes
Other Study ID Numbers: 09-03-017
Protocol #09-03-017 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
Study First Received: June 4, 2009
Results First Received: October 2, 2012
Last Updated: May 5, 2017