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

NCT03313401 | Completed FDA Drug FDA Device

• 1 other identifier: 16952
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• specular microscopic evaluation of corneal endothelium

  change in endothelial cell density

  Before the first intravitreal aflibercept injection and 1, 3, 6 months after the intravitreal aflibercept injection

Interventions

Aflibercept DRUG

Intravitreal aflibercept injection

Also known as: eylae

Specular microscopy DEVICE

Specular microscopy measurement after intravitreal aflibercept injection

Also known as: Tomey-EM-3000

Eligibility Criteria

• Age: 55 Years - 76 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with neovascular age related macular degeneration

You may not qualify if:

• age more than 80 years
• specific corneal conditions such as Fuchs endothelial dystrophy and other corneal endothelial dystrophies
• history of ocular surgery
• history of contact lenses use
• ocular and systemic diseases such as diabetes and connective tissue disorders that could effect the corneal endothelium

Sponsors & Collaborators

• Ulucanlar Eye Training and Research Hospital: lead

Related Publications (3)

• de Oliveira Dias JR, de Andrade GC, Novais EA, Farah ME, Rodrigues EB. Fusion proteins for treatment of retinal diseases: aflibercept, ziv-aflibercept, and conbercept. Int J Retina Vitreous. 2016 Feb 1;2:3. doi: 10.1186/s40942-016-0026-y. eCollection 2016.

  PMID: 27847621 RESULT

• Stewart MW, Rosenfeld PJ. Predicted biological activity of intravitreal VEGF Trap. Br J Ophthalmol. 2008 May;92(5):667-8. doi: 10.1136/bjo.2007.134874. Epub 2008 Mar 20.

  PMID: 18356264 RESULT

• Ammar DA, Mandava N, Kahook MY. The effects of aflibercept on the viability and metabolism of ocular cells in vitro. Retina. 2013 May;33(5):1056-61. doi: 10.1097/IAE.0b013e31827b646d.

  PMID: 23266881 RESULT

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Sibel Doguizi, M.D.

  Ulucanlar Eye Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 18, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share