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

NCT03313401 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2017-10-19

No results posted yet for this study

Summary

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.

Conditions

  • Age Related Macular Degeneration

Interventions

DRUG

Aflibercept

Intravitreal aflibercept injection

DEVICE

Specular microscopy

Specular microscopy measurement after intravitreal aflibercept injection

Sponsors & Collaborators

  • Ulucanlar Eye Training and Research Hospital

    lead OTHER

Principal Investigators

  • Sibel Doguizi, M.D. · Ulucanlar Eye Training and Research Hospital

Eligibility

Min Age
55 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-05-31
Completion
2017-06-30
FDA Drug
Yes
FDA Device
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313401 on ClinicalTrials.gov