25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China

Sponsor
JUNYAN ZHANG
Study ID
NCT02328118
Phase
PHASE2/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 patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
  • Triamcinolone Acetonide — DRUG
    A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetone group will receive Triamcinolone Acetone 4mg/0.1 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during 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
Dec 31, 2014
Start date
Feb 28, 2015
Status verified
Aug 2016
Primary completion
Mar 31, 2017
Completion
May 31, 2017

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.5 mg
    All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.
  • Experimental: Triamcinolone Acetonide 4mg
    All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.

Primary Outcome Measure

composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy [ Time Frame: 12 months after the last subject accepts vitrectomy ]

Central Contacts