Retinal Detachment, Vitreoretinopathy Proliferative
Conditions
Keywords
pvr, rd, Proliferative Vitreoretinopathy, retinal detachment, detachment
Brief summary
The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on the rates of recurrent retinal detachment and scar tissue formation.
Detailed description
Proliferative vitreoretinopathy (PVR) remains the most significant obstacle to successful retinal detachment (RD) repair, accounting for up to 75% of all primary surgical failures. Characterized by the proliferation of cells on the preretinal or subretinal surface, PVR ultimately leads to contraction, foreshortening, and ultimately recurrent detachment of the retina. Several PVR risk factors have been identified, including pre-existing uveitis, large retinal tears, multiple retinal breaks, detachments involving greater than two quadrants of the retina, vitreous hemorrhage, and choroidal detachment. Given the absence of a proven medical therapy for PVR and prior studies establishing VEGF as a potential therapeutic target, further clinical evaluation is warranted. Herein, we report outcomes of a prospective, non-randomized, historical-control pilot study evaluating the effect of serial intrasilicone oil bevacizumab injections on outcomes of PVR-related RD repair.
Interventions
DRUGBevacizumab
Bevacizumab (1.25mg/0.05mL) will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
Sponsors
Wills Eye
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Outcomes were compared to a retrospective, historical control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study * Undergoing pars plana vitrectomy with or without scleral buckling for recurrent RD due to PVR with planned silicone oil instillation.
Exclusion criteria
* Prior anti-VEGF (vascular endothelial growth factor) injections within 3 months of retinal detachment surgery. * Traction retinal detachment due to proliferative diabetic retinopathy. * Inability to flatten retina completely intraoperatively * Known allergy or contraindication to intravitreal bevacizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease) | up to 6 months | This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease) | 6 months | To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes . |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read). | 6 months | Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)
This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.
Time frame: up to 6 months
Population: Bevacizumab treated patients with recurrent retinal detachment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bevacizumab | The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease) | 6 Participants |
Secondary
The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)
To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .
Time frame: 6 months
Population: Number of patients treated with bevacizumab who developed epiretinal membrane
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bevacizumab | The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease) | 7 Participants |
Other Pre-specified
Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).
Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.
Time frame: 6 months
Population: Final logMAR visual acuity of patients treated with bevacizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab | Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read). | 1.43 logMAR visual acuity | Standard Deviation 0.7 |