Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Conditions
Keywords
Intravitreal Bevacizumab, Tractional Retinal Detachment, Proliferative Diabetic Retinopathy, Small gauge pars plana vitrectomy, Intraoperative bleeding, Post-operative vitreous hemorrhage, Visual acuity
Brief summary
The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy \[TSV\]). In addition, post-operative rebleeding may be decreased.
Detailed description
This will be a prospective, randomized, active-controlled study of 224 eyes of patients with the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility. Eligible patients will be examined at baseline to determine their ocular condition and randomized into 2 arms. Patients will be randomized in a 1:1 ratio to the study arm. 1. Control arm: PPV without pre-operative bevacizumab (Sham injection). 2. Study arm: Pre-operative bevacizumab (3-5 days) before PPV. In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS). The purpose of the current study is to determine the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR.
Interventions
A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.
PROCEDURESmall-gauge pars plana vitrectomy
Sponsors
Pan American Collaborative Retina Study Group
J. Fernando Arevalo, MD FACS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea. 2. Diagnosis of diabetes mellitus (type 1 or type 2) 3. At least one eye meets the study eye criteria 4. One eye per patient will be included 5. Able and willing to provide informed consent prior to any study-related procedures 6. Best corrected visual acuity 20/40 or less 7. Willing and able to comply with clinic visits and study-related procedures 8. U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws
Exclusion criteria
Ocular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity change | 12 months | Mean change in best-corrected visual acuity (BCVA) at 12 months |
| Intraoperative bleeding | 12 months | — |
| Total surgical time | 12 months | — |
| Post-operative vitreous hemorrhage | 12 months | Early (\<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of eyes gaining at least 15 letters of BCVA | 12 months |
| Number of endodiathermy applications | 12 months |
| Intraoperative breaks | 12 months |
| Change in central macular thickness | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Molecules in the vitreous humor and epiretinal membranes | 12 months | We would now like to examine molecules in the vitreous humor and epiretinal membranes to gain insight and better assess the efficacy and outcomes of pre-operative intravitreal bevacizumab. |
Countries
Saudi Arabia
Outcome results
None listed