Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group

J. Fernando Arevalo, MD FACS1 site in 1 country224 target enrollmentNovember 2013

ConditionsTractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

InterventionsIntravitreal bevacizumab Small-gauge pars plana vitrectomy

DrugsIntravitreal bevacizumab

Overview

Phase: Phase 3
Intervention: Intravitreal bevacizumab
Conditions: Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Sponsor: J. Fernando Arevalo, MD FACS
Enrollment: 224
Locations: 1
Primary Endpoint: Total surgical time
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

October 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

J. Fernando Arevalo, MD FACS

Responsible Party

Sponsor Investigator

Principal Investigator

J. Fernando Arevalo, MD FACS

Chief of Vitreoretina Division

King Khaled Eye Specialist Hospital

Eligibility Criteria

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

•Ocular Exclusion Criteria
•The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):
•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