Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone

NCT00931125 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-10-16

No results posted yet for this study

Summary

This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.

Conditions

Interventions

DRUG

ranibizumab and vitrectomy

ranibizumab 10mg/ml intravitreal injection, 0,05 ml

PROCEDURE

vitrectomy without preoperative ranibizumab

sham intravitreal injection before vitrectomy surgery

Sponsors & Collaborators

  • Semmelweis University

    collaborator OTHER
  • Attila Vajas

    lead OTHER

Principal Investigators

  • Attila Vajas, MD · National Institute of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Hungary

Study Locations

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Entities

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 NCT00931125 on ClinicalTrials.gov