Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy

Sponsor
Pusan National University Hospital
Study ID
NCT02976194
Phase
PHASE4
Status
Unknown

Conditions

  • Exudative Age-related Macular Degeneration
  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.

Study Details

Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.

Key Dates

First listed
Nov 29, 2016
Start date
Nov 22, 2016
Status verified
Oct 2019
Primary completion
Nov 30, 2019
Completion
Jan 31, 2020

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: pro-re-nata
    Ranibizumab 0.5mg is injected in to the vitreous cavity. An injection is given every 4 weeks three times, and then the patient will be followed up every 4 weeks. An addition injection is given as needed. Recurrence is defined as increase of exudative changes, or increase of 10% or more in central subfield macular thickness (CSMT) measured using optical coherence tomography. Aqueous humor is sampled from the anterior chamber before injection at baseline, 8 weeks and 20 weeks.

Primary Outcome Measure

Changes of VEGF-A from 8 weeks to 20 weeks [ Time Frame: 8 weeks and 20 weeks ]

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