Trial Outcomes & Findings for Topical IL-1-Ra for Treatment of Corneal Neovascularization (NCT NCT00915590)
NCT ID: NCT00915590
Last Updated: 2017-05-08
Results Overview
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
TERMINATED
PHASE1/PHASE2
10 participants
64 Weeks
2017-05-08
Participant Flow
Patients in this study were recruited from Mass. Eye and Ear Infirmary from May 2009 - February 2010.
This is a single site, randomized, double masked, crossover, phase I/II study of topical IL-1Ra (5.0%) in subjects with corneal neovascularization.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical IL-1-Ra for Treatment of Corneal Neovascularization
Baseline characteristics by cohort
| Measure |
Placebo First, Then IL-1Ra
n=5 Participants
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
n=5 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 24 • n=99 Participants
|
66 years
STANDARD_DEVIATION 19 • n=107 Participants
|
56 years
STANDARD_DEVIATION 22 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 64 WeeksIncidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Outcome measures
| Measure |
Placebo First, Then IL-1RA
n=5 Participants
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
|
IL-1RA First, Then Placebo
n=5 Participants
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
|
|---|---|---|
|
Incidence and Severity of Ocular Adverse Event
|
2 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 64 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 64 WeeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 64 WeeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 64 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 64 WeeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
IL-1Ra
Off Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks
|
IL-1Ra
n=10 participants at risk
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
|
Off Treatment
n=10 participants at risk
Off treatment
|
|---|---|---|---|
|
Eye disorders
Itchy Eyes
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
10.0%
1/10 • Number of events 2 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
|
Eye disorders
Eye Redness
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
|
Eye disorders
Eye Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
|
Eye disorders
Diminished Vision
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
|
Eye disorders
Ocular Herpes Flare-up
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
|
Gastrointestinal disorders
Gall Bladder Hospitalization
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
0.00%
0/10 • Adverse events were collected over a 9 month period (May 2009 - February 2010).
|
Additional Information
Reza Dana, MD, MPH, MSc
Massachusetts Eye and Ear Infirmary
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place