Trial Outcomes & Findings for Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients (NCT NCT00884039)
NCT ID: NCT00884039
Last Updated: 2018-08-14
Results Overview
Intraocular pressure was measured by Goldmann applanation tonometry.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
1 month
Results posted on
2018-08-14
Participant Flow
Participant milestones
| Measure |
30 mg Anecortave Acetate
|
15 mg Anecortave Acetate
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
30 mg Anecortave Acetate
|
15 mg Anecortave Acetate
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
Baseline Characteristics
Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients
Baseline characteristics by cohort
| Measure |
30 mg Anecortave Acetate
n=5 Participants
|
15 mg Anecortave Acetate
n=2 Participants
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 19 • n=5 Participants
|
70 years
STANDARD_DEVIATION 2 • n=7 Participants
|
65 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Per protocol
Intraocular pressure was measured by Goldmann applanation tonometry.
Outcome measures
| Measure |
30 mg Anecortave Acetate
n=5 Participants
|
15 mg Anecortave Acetate
n=2 Participants
|
|---|---|---|
|
Intraocular Pressure Within Normal Limits (<24 mm Hg)
|
2 Participants
|
1 Participants
|
Adverse Events
30 mg Anecortave Acetate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
15 mg Anecortave Acetate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
30 mg Anecortave Acetate
n=5 participants at risk
|
15 mg Anecortave Acetate
n=2 participants at risk
|
|---|---|---|
|
Eye disorders
Intraocular pressure elevation
|
80.0%
4/5 • Number of events 5
|
100.0%
2/2 • Number of events 3
|
|
Eye disorders
Eye discomfort
|
20.0%
1/5 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Eye disorders
Cornea transplant rejection episode
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
Additional Information
Marianne Price, PhD
Cornea Research Foundation of America
Phone: 317-814-2990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place