At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 69 enrolled

Drug / intervention

Bevacizumab +2 moredrug

Likely dose

Bevacizumab 0.16 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01854593

NCT01854593Phase 4Completed

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Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy

Nihon University·interventional·Posted May 15, 2013·Updated Jul 14, 2014

In Brief

A Phase 4 clinical trial evaluating Bevacizumab, Vitrectomy, and 1 other intervention for Proliferative Diabetic Retinopathy and 2 related conditions. Completed, enrolled 69 participants across 1 site.

Detailed Summary

We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProliferative Diabetic Retinopathy, Diabetic Traction Retinal Detachment, Vitreous Hemorrhage

CountriesJapan

Collaborators--

Timeline

Phase 4CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartMay 2012

First PostedMay 2013

Primary CompletionAug 2013

Study CompletionMar 2014

TodayJul 2026

First PostedMay 15, 2013

Enrollment StartMay 1, 2012

Primary CompletionAug 1, 2013

Study CompletionMar 1, 2014

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 13.1 years ago

Interventions

Bevacizumabdrug

0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)

Vitrectomyprocedure

vitrectomy of 25 gauge system.

Sham injectiondevice

Sham injection one day before vitrectomy