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Ranibizumab for Diabetic Traction Retinal Detachment

NCT ID: NCT01201161

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

Detailed Description

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Conditions

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Diabetic Retinopathy Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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RANI/PPV

Preoperative intravitreal ranibizumab and pars plana vitrectomy

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy

PPV

Sham injection and pars plana vitrectomy

Group Type PLACEBO_COMPARATOR

Sham injection

Intervention Type OTHER

Simulation of intravitreal injection one week before pars plana vitrectomy

Interventions

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Ranibizumab

Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy

Intervention Type DRUG

Sham injection

Simulation of intravitreal injection one week before pars plana vitrectomy

Intervention Type OTHER

Other Intervention Names

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Lucentis

Eligibility Criteria

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Inclusion Criteria

* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria

* Massive vitreous hemorrhage preventing from detailed posterior pole examination;
* Previous intra-ocular surgery other than cataract surgery
* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
* Prothrombin time, partial thromboplastin time or platelet count without normal limits
* History of previous thromboembolic events
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Rodrigo Jorge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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RANITRA

Identifier Type: -

Identifier Source: org_study_id