Diabetic Retinopathy, Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment
Conditions
Keywords
Intravitreal Bevacizumab injection, Pars plana vitrectomy, tractional retinal detachment, Diabetic retinopathy
Brief summary
Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used. Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery.. In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation. During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.
Detailed description
Eligibility criteria: Diabetic tractional retinal detachment-complexity score between 4 and 8 Main outcome measures: best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)
Interventions
DRUGBevacizumab
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Sponsors
Iran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy. * Complexity score between 4 and 8.
Exclusion criteria
* Previous vitreoretinal surgery. * Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | last follow up, an average of 7 months post-operation | Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic Status of the Retina | Last follow up, an average of 7 months post-operation | Number of Participants with Postoperative Vitreous Hemorrhage |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy
Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy | 22 |
| Control no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy | 18 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 11.3 | 53.2 years STANDARD_DEVIATION 11.7 | 54.63 years STANDARD_DEVIATION 11.48 |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 |
| other Total, other adverse events | 0 / 22 | 0 / 18 |
| serious Total, serious adverse events | 1 / 22 | 1 / 18 |
Outcome results
Primary
Best Corrected Visual Acuity
Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
Time frame: last follow up, an average of 7 months post-operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Best Corrected Visual Acuity | 1.1 LogMar | Standard Deviation 0.4 |
| Control | Best Corrected Visual Acuity | 1.4 LogMar | Standard Deviation 0.3 |
Secondary
Anatomic Status of the Retina
Number of Participants with Postoperative Vitreous Hemorrhage
Time frame: Last follow up, an average of 7 months post-operation
Population: Postoperative Vitreous Hemorrhage
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Anatomic Status of the Retina | 0 Participants |
| Control | Anatomic Status of the Retina | 7 Participants |