Trial Outcomes & Findings for Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients (NCT NCT01214174)
NCT ID: NCT01214174
Last Updated: 2013-09-18
Results Overview
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
8 days post-treatment
Results posted on
2013-09-18
Participant Flow
Participant milestones
| Measure |
Dose 1
IBI-10090 513ug
|
Dose 2
IBI-10090 776ug
|
Dose 3
IBI-10090 1046ug
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
14
|
|
Overall Study
COMPLETED
|
13
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dose 1
IBI-10090 513ug
|
Dose 2
IBI-10090 776ug
|
Dose 3
IBI-10090 1046ug
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
Baseline characteristics by cohort
| Measure |
Dose 1
n=13 Participants
IBI-10090 513ug
|
Dose 2
n=16 Participants
IBI-10090 776ug
|
Dose 3
n=13 Participants
IBI-10090 1046ug
|
Total
n=42 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Age Continuous
|
70.9 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
73.5 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
72.3 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
42 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 days post-treatmentThis study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
Outcome measures
| Measure |
Dose 1
n=13 Participants
IBI-10090 513ug
|
Dose 2
n=16 Participants
IBI-10090 776ug
|
Dose 3
n=13 Participants
IBI-10090 1046ug
|
|---|---|---|---|
|
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
|
30.8 percentage of patients with ACC clearing
Interval 5.68 to 55.86
|
25 percentage of patients with ACC clearing
Interval 3.78 to 46.22
|
46.2 percentage of patients with ACC clearing
Interval 19.05 to 73.25
|
Adverse Events
Dose 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Dose 2
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Dose 3
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose 1
n=13 participants at risk
IBI-10090 513ug
|
Dose 2
n=16 participants at risk
IBI-10090 776ug
|
Dose 3
n=13 participants at risk
IBI-10090 1046ug
|
|---|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/13
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/13
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/13
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/13
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Dose 1
n=13 participants at risk
IBI-10090 513ug
|
Dose 2
n=16 participants at risk
IBI-10090 776ug
|
Dose 3
n=13 participants at risk
IBI-10090 1046ug
|
|---|---|---|---|
|
Eye disorders
Eye Disorders
|
76.9%
10/13 • Number of events 13
|
81.2%
13/16 • Number of events 25
|
92.3%
12/13 • Number of events 19
|
|
Infections and infestations
Infections and Infestations
|
7.7%
1/13 • Number of events 1
|
0.00%
0/16
|
38.5%
5/13 • Number of events 5
|
|
Investigations
Investigations
|
15.4%
2/13 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
38.5%
5/13 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information related to this study is considered confidential information belonging to Icon Bioscience, Inc. Data on the use of the study drug and results of all clinical and laboratory studies are considered private and confidential. None of the details, results, or other information for this study shall be published or made known to a third party without written consent from Icon Bioscience, Inc., except for disclosure to regulatory agencies if required by law.
- Publication restrictions are in place
Restriction type: OTHER