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Topical IL-1-Ra for Treatment of Corneal Neovascularization

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: NCT00915590
Recruitment Status : Terminated
First Posted : June 8, 2009
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Corneal Neovascularization
Interventions Drug: Placebo
Drug: IL-1Ra
Enrollment 10
Recruitment Details Patients in this study were recruited from Mass. Eye and Ear Infirmary from May 2009 - February 2010.
Pre-assignment Details This is a single site, randomized, double masked, crossover, phase I/II study of topical IL-1Ra (5.0%) in subjects with corneal neovascularization.
Arm/Group Title Placebo First, Then IL-1Ra IL-1Ra First, Then Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 5 5
Completed 3 4
Not Completed 2 1
Arm/Group Title Placebo First, Then IL-1Ra IL-1Ra First, Then Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
53  (24) 66  (19) 56  (22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
2
  40.0%
2
  40.0%
4
  40.0%
Male
3
  60.0%
3
  60.0%
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Incidence and Severity of Ocular Adverse Event
Hide Description Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Time Frame 64 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then IL-1RA IL-1RA First, Then Placebo
Hide Arm/Group Description:

It is our intent that 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

It is our intent that 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

Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
2 3
2.Primary Outcome
Title Extent of Neovascular Area (NA)
Hide Description The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Time Frame 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Arm/Group Title Placebo First, Then IL-1RA IL-1RA First, Then Placebo
Hide Arm/Group Description:

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

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

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

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

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels
Hide Description The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Time Frame 64 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Arm/Group Title Placebo First, Then IL-1Ra IL-1Ra First, Then Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels
Hide Description The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Time Frame 64 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Arm/Group Title Placebo First, Then IL-1Ra IL-1Ra First, Then Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Best Spectacle-Corrected Visual Acuity (BSCVA)
Hide Description The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Time Frame 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Arm/Group Title Placebo First, Then IL-1Ra IL-1Ra First, Then Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Central Corneal Thickness
Hide Description The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Time Frame 64 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Arm/Group Title Placebo First, Then IL-1Ra IL-1Ra First, Then Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected over a 9 month period (May 2009 - February 2010).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo IL-1Ra Off Treatment
Hide Arm/Group Description Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks Off treatment
All-Cause Mortality
Placebo IL-1Ra Off Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo IL-1Ra Off Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo IL-1Ra Off Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      1/10 (10.00%)      2/10 (20.00%)    
Eye disorders       
Itchy Eyes *  0/10 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0
Eye Redness *  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Eye Pain *  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Diminished Vision *  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Ocular Herpes Flare-up *  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders       
Gall Bladder Hospitalization   1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Reza Dana, MD, MPH, MSc
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-3313
EMail: Cornea_Research@meei.harvard.edu
Layout table for additonal information
Responsible Party: Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00915590    
Other Study ID Numbers: 09-03-017
Protocol #09-03-017 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
First Submitted: June 4, 2009
First Posted: June 8, 2009
Results First Submitted: October 2, 2012
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017