NCT04464694

Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

Detailed description

Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy. Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy. Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.

Conditions

• Proliferative Diabetic Retinopathy
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Ranibizumab	Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\~7 days before vitrectomy.
OTHER	Sham injection	Patients will receive single sham injection 3\~7 days before vitrectomy.
PROCEDURE	Pars plana vitrectomy	Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2020-07-09
• Last updated: 2020-07-09

Locations

3 sites across 1 country: China