Trial Outcomes & Findings for Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity (NCT NCT00634972)
NCT ID: NCT00634972
Last Updated: 2020-12-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
3-4 years
Results posted on
2020-12-08
Participant Flow
Participant milestones
| Measure |
1 Drop of the ROP Study Drug
ACULAR: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
REFRESH TEARS: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
|
Placebo
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
|
Overall Study
COMPLETED
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1 Drop of the ROP Study Drug
n=40 Participants
ACULAR: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
REFRESH TEARS: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
|
Placebo
n=43 Participants
placebo
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=40 Participants
|
43 Participants
n=43 Participants
|
83 Participants
n=83 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=83 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=83 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=40 Participants
|
19 Participants
n=43 Participants
|
41 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=40 Participants
|
24 Participants
n=43 Participants
|
42 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3-4 yearsPopulation: The study was prematurely interrupted. As we could not achieve the recruitment of a sufficient number of patients that was required to reach the preplanned power for a statistically significant results, no data analysis was completed.
Outcome measures
Outcome data not reported
Adverse Events
1 Drop of the ROP Study Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place