Effect of Aflibercept on Human Corneal Endothelial Cells in Neovascular Age-Related Macular Degeneration

Sponsor
Ulucanlar Eye Training and Research Hospital
Study ID
NCT03313401
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    Intravitreal aflibercept injection
  • Specular microscopy — DEVICE
    Specular microscopy measurement after intravitreal aflibercept injection

Study Details

Aflibercept is the most recently developed VEGF inhibitor with a recombinant fusion protein consisting of human VEGF receptor extracellular domains from receptors 1 and 2 (VEGFR1 and VEGFR2) fused to the Fc domain of human IgG. Although both ranibizumab and bevacizumab have been shown not to have harmful effects on corneal endothelium, the effect of intravitreal aflibercept on human corneal endothelium has not been reported so far. Considering the functional importance of the corneal endothelium, particularly in aged population, the present study was designed to evaluate the in vivo toxicity of aflibercept on human corneal endothelial cells in patients with neovascular AMD. This study showed that intravitreal injection of clinically effective doses of aflibercept for four times on average during the 6-month period do not induce any harmful effect on human corneal endothelium evaluated by specular microscopy. Further prospective, large-scale, prolonged studies are needed to confirm that intravitreal aflibercept can be used safely without any corneal toxicity to treat neovascular AMD.

Key Dates

Start date
Jan 31, 2017
Status verified
Oct 2017
Primary completion
May 31, 2017
Completion
Jun 30, 2017

Study Design

Enrollment
34 participants (actual)

Primary Outcome Measure

specular microscopic evaluation of corneal endothelium [ Time Frame: Before the first intravitreal aflibercept injection and 1, 3, 6 months after the intravitreal aflibercept injection ]

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