Ranibizumab for Diabetic Traction Retinal Detachment (RANITRA)

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Retinal Detachment; Diabetic Retinopathy

Treatments: Drug: Ranibizumab; Other: Sham injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01201161

RANITRA

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

RANI/PPV

Experimental group

Description:

Preoperative intravitreal ranibizumab and pars plana vitrectomy

Treatment:

Drug: Ranibizumab

PPV

Placebo Comparator group

Description:

Sham injection and pars plana vitrectomy

Treatment:

Other: Sham injection