Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
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.
Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Drug: Intravitreal bevacizumab
Procedure: Small-gauge pars plana vitrectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group|
- Intraoperative bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Total surgical time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Post-operative vitreous hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
- Visual acuity change [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mean change in best-corrected visual acuity (BCVA) at 12 months
- Number of endodiathermy applications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Intraoperative breaks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in central macular thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Proportion of eyes gaining at least 15 letters of BCVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Molecules in the vitreous humor and epiretinal membranes [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Study arm
Intravitreal bevacizumab Small-gauge pars plana vitrectomy
Drug: Intravitreal bevacizumab
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.Procedure: Small-gauge pars plana vitrectomy
Sham Comparator: Control arm
Small-gauge pars plana vitrectomy
|Procedure: Small-gauge pars plana vitrectomy|
This will be a prospective, randomized, active-controlled study of 374 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 3:1 ratio to the study arm.
- Control arm: PPV without pre-operative bevacizumab (Sham injection).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976923
|King Khaled Eye Specialist Hospital|
|Riyadh, Saudi Arabia, 11462|