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Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

NCT01976923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

  • Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

Interventions

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

Sponsors & Collaborators

  • Pan American Collaborative Retina Study Group

    collaborator NETWORK

  • J. Fernando Arevalo, MD FACS

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-07-31
Completion
2018-10-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976923 on ClinicalTrials.gov