Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
|Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy||Drug: Intravitreal bevacizumab Procedure: Small-gauge pars plana vitrectomy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
- Total surgical time [ Time Frame: 12 months ]
- Post-operative vitreous hemorrhage [ Time Frame: 12 months ]Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
- Visual acuity change [ Time Frame: 12 months ]Mean change in best-corrected visual acuity (BCVA) at 12 months
- Number of endodiathermy applications [ Time Frame: 12 months ]
- Intraoperative breaks [ Time Frame: 12 months ]
- Change in central macular thickness [ Time Frame: 12 months ]
- Proportion of eyes gaining at least 15 letters of BCVA [ Time Frame: 12 months ]
- Molecules in the vitreous humor and epiretinal membranes [ Time Frame: 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.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||July 2017 (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|