Trial Outcomes & Findings for Isotretinoin for Proliferative Vitreoretinopathy (NCT NCT01445028)
NCT ID: NCT01445028
Last Updated: 2018-06-01
Results Overview
We will evaluate all patients for retinal attachment at 3 months.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
3 months
Results posted on
2018-06-01
Participant Flow
Participant milestones
| Measure |
Primary, High-risk Retinal Detachment
Isotretinoin: Isotretinoin 20mg daily for 12 weeks
|
Recurrent RD Associated With PVR
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
54
|
|
Overall Study
COMPLETED
|
58
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Isotretinoin for Proliferative Vitreoretinopathy
Baseline characteristics by cohort
| Measure |
Primary, High-risk Retinal Detachment
n=58 Participants
Isotretinoin: Isotretinoin 20mg daily for 12 weeks
|
Recurrent RD Associated With PVR
n=51 Participants
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 10.0 • n=93 Participants
|
59.7 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
57.1 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=93 Participants
|
51 participants
n=4 Participants
|
109 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsWe will evaluate all patients for retinal attachment at 3 months.
Outcome measures
| Measure |
Primary, High-risk Retinal Detachment
n=58 Participants
Isotretinoin: Isotretinoin 20mg daily for 12 weeks
|
Recurrent RD Associated With PVR
n=51 Participants
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks
|
|---|---|---|
|
Rate of Retinal Attachment
|
50 Participants
|
42 Participants
|
Adverse Events
Primary, High-risk Retinal Detachment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recurrent RD Associated With PVR
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