Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy

Sponsor
Aier School of Ophthalmology, Central South University
Study ID
NCT02806752
Phase
PHASE4
Status
Unknown

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Triamcinolone Acetonide — DRUG
    Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
  • Ranibizumab — DRUG
    Intravitreal inject 0.5mg of Ranibizumab.

Study Details

The purpose of this study is to evaluate the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes polymorphism in response to the treatments. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV.

Key Dates

First listed
Jun 21, 2016
Start date
Jan 31, 2017
Status verified
Nov 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

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

Arms

  • Experimental: Ranibizumab + Triamcinolone Acetonide
    intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
  • Active Comparator: Ranibizumab
    intravitreal injection: Ranibizumab 0.5mg

Primary Outcome Measure

Change of mean BCVA [ Time Frame: 12 months ]

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