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

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT04464694
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jul 9, 2020
Start date
Sep 1, 2020
Status verified
Jul 2020
Primary completion
Dec 1, 2021
Completion
Jun 1, 2022

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    Single intravitreal injection of ranibizumab (0.5 mg) 3\~7 days before vitrectomy
  • Sham Comparator: Sham injection
    Sham injection 3\~7 days before vitrectomy

Primary Outcome Measure

Early postoperative vitreous haemorrhage [ Time Frame: From day 1 to week 4 after the vitrectomy ]

Central Contacts

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