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
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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