Proliferative Vitreoretinopathy, Retinal Detachment
Conditions
Keywords
Retinal detachment, Proliferative vitreoretinopathy
Brief summary
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.
Interventions
DRUGBevacizumab
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Eyes with rhegmatogenous retinal detachment
Exclusion criteria
* Presence of PVR * Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy. * Recent intravitreal injection of an anti-VEGF agent less than 3 months prior * Secondary retinal detachment repair * Use of silicone oil as tamponade agent * Patients less than 18 years of age * Pregnancy * Known allergy or contraindication to intravitreal bevacizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery | 6 months | Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy | 6 months |
Countries
United States
Participant flow
Pre-assignment details
The comparison arm is a chart review, participants were not enrolled in prospective study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 101 |
| 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. | 195 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 0 |
Baseline characteristics
| Characteristic | Chart Review | Total | Bevacizumab |
|---|---|---|---|
| Age, Continuous | 58.8 years | 59.7 years | 61.4 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 195 participants | 296 participants | 101 participants |
| Sex: Female, Male Female | 64 Participants | 98 Participants | 34 Participants |
| Sex: Female, Male Male | 131 Participants | 198 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 0 |
| other Total, other adverse events | 0 / 101 | 0 / 0 |
| serious Total, serious adverse events | 0 / 101 | 0 / 0 |
Outcome results
Primary
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bevacizumab | Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery | 92 Participants |
| Chart Review | Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery | 169 Participants |
Secondary
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bevacizumab | Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy | 9 Participants |
| Chart Review | Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy | 26 Participants |