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OpenTrials
Completed

NCT Number: NCT01201161

Ranibizumab for Diabetic Traction Retinal Detachment

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Eye Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Detachment Retinal Diseases Vascular Diseases Vitreous Hemorrhage

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

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

Other names: Lucentis

Sham Injection

Other

Simulation of intravitreal injection one week before pars plana vitrectomy

Primary outcomes

  1. amount of intraoperative intra-ocular bleeding

    Time frame: one week

    amount of intra-ocular bleeding that occurred during pars plana vitrectomy

Secondary outcomes

  1. visual acuity

    Time frame: 12 weeks

    ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment

Acronym: RANITRA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2010
Registry last updated
Sep 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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