Viewing Study NCT01976923



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Study NCT ID: NCT01976923
Status: COMPLETED
Last Update Posted: 2018-10-09
First Post: 2013-10-25

Brief Title: Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Sponsor: J Fernando Arevalo MD FACS
Organization: King Khaled Eye Specialist Hospital

Study Overview

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
Status: COMPLETED
Status Verified Date: 2018-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 11 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 125 µg005 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 125 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None