Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferati… (NCT01976923) | Clinical Trial Compass
CompletedPhase 3
Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Saudi Arabia224 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
✓. Diagnosis of diabetes mellitus (type 1 or type 2)
✓. At least one eye meets the study eye criteria
✓. One eye per patient will be included
✓. Able and willing to provide informed consent prior to any study-related procedures
✓. Best corrected visual acuity 20/40 or less
✓. Willing and able to comply with clinic visits and study-related procedures
✓. 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
✕. TRD is considered to be due to a cause other than diabetes.
. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
✕. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
✕. History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs.
✕. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization.
✕. History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization.
✕. Intraocular pressure \>= 25 mmHg.
✕. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis