25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial

Sponsor
JUNYAN ZHANG
Study ID
NCT02447185
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. All subjects in Ranibizumab group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
  • Triamcinolone Acetonide — DRUG
    A week before 25-gauge vitrectomy, all subjects in TA group will receive Triamcinolone Acetonide 4mg/0.1ml intravitreal injection. During operation all subjects in Ranibizumab group and in TA group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in TA group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation.

Study Details

Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.

Key Dates

First listed
May 18, 2015
Start date
Jun 30, 2015
Status verified
Sep 2018
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Ranibizumab
    A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in this group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
  • Active Comparator: Triamcinolone Acetonide
    A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetonide group will receive Triamcinolone Acetonide 4mg/0.1 ml intravitreal injection. During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in this group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation.

Primary Outcome Measure

intraoperative bleeding [ Time Frame: during operation of 25-G Vitrectomy ]

Central Contacts