Trial Outcomes & Findings for Bevacizumab Against Recurrent Retinal Detachment (NCT NCT02192970)
NCT ID: NCT02192970
Last Updated: 2021-03-26
Results Overview
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-26
Participant Flow
The comparison arm is a chart review, participants were not enrolled in prospective study.
Participant milestones
| Measure |
Bevacizumab
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
Bevacizumab
|
Chart Review
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
195
|
|
Overall Study
COMPLETED
|
95
|
195
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Bevacizumab
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
Bevacizumab
|
Chart Review
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=101 Participants
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
Bevacizumab
|
Chart Review
n=195 Participants
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
n=101 Participants
|
58.8 years
n=195 Participants
|
59.7 years
n=296 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=101 Participants
|
64 Participants
n=195 Participants
|
98 Participants
n=296 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=101 Participants
|
131 Participants
n=195 Participants
|
198 Participants
n=296 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
101 participants
n=101 Participants
|
195 participants
n=195 Participants
|
296 participants
n=296 Participants
|
PRIMARY outcome
Timeframe: 6 monthsComplete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
Outcome measures
| Measure |
Bevacizumab
n=101 Participants
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
Bevacizumab
|
Chart Review
n=195 Participants
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
|
|---|---|---|
|
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
|
92 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Bevacizumab
n=101 Participants
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
Bevacizumab
|
Chart Review
n=195 Participants
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
|
|---|---|---|
|
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
|
9 Participants
|
26 Participants
|
Adverse Events
Bevacizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chart Review
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
Michael M Altaweel, MD
University of Wisconsin - Madison
Phone: (608) 263-7290
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place