Corneal Neovascularization Clinical Trial
Official title:
The Effect of Subconjunctival Aflibercept on Regression of Corneal Neovascularization
The goal of this current study is to prospectively evaluate the influence of a single subconjunctival aflibercept injection on the regression of corneal neovascularization. Twenty patients with corneal neovascularization who are candidates for anti VEGF treatment (by the discretion of a corneal specialist) will be included in this study. The patients will be treated with a single subconjunctival injection of 0.08 ml aflibercept (25 mg/ml) in a single quarter of the conjunctiva, near the limbus in a proximity to the area of pathological neovascularization. Regression of neovascularization will be documented.
An interruption of the equilibrium between proangiogenic and antiangiogenic factors in the
usually nonvascularized cornea causes new corneal vessels to sprout, interfering with the
corneal clarity that is essential for maintaining normal vision. Treating the neovascularized
and often scarred cornea remains highly challenging because the loss of immunologic privilege
in the avascular cornea makes it a poor candidate for corneal transplantation.
Vascular endothelial growth factor (VEGF) is a key cytokine in the development of both normal
blood vessels and vessels in tumors and other tissues undergoing abnormal angiogenesis. In
the cornea, VEGF is one of several known mediators of neovascularization. In recent years,
anti-VEGF compounds have been extensively investigated for use in the prevention and
treatment of neovascularization in many tissues, including the cornea. Experimental models
and clinical studies have reported promising results for such anti-VEGF compounds as
bevacizumab (Avastin®) and ranibizumab (Lucentis®). Aflibercept is a VEGF-Trap molecule. It
has the highest affinity of all VEGF blockers studied to date. Aflibercept has been approved
in the United States and Europe for the treatment of macular degeneration under the trade
name Eylea® and the treatment of metastatic colorectal cancer under the trade name Zaltrap®.
It has been found to offer a more prolonged and potentially more potent anti-VEGF effect in
wet age-related macular degeneration than both bevacizumab and ranibizumab. Aflibercept's
safety has been proven for this indication.
A preliminary study in a rat model recently conducted by our group demonstrated that
subconjunctival (SC) injection and topical administration of aflibercept efficiently
prevented corneal neovascularization compared to bevacizumab. The aim of this present study
is to determine aflibercept's efficacy in the treatment of corneal neovascularization in
humans.
Goal:
To prospectively evaluate the influence of a single subconjunctival aflibercept injection on
the regression of corneal neovascularization.
Design and Clinical Follow-up:
A prospective study, including patients with various corneal pathologies complicated by
corneal neovascularization.
Twenty patients with corneal neovascularization who are candidates for anti VEGF treatment
(by the discretion of a corneal specialist) will be included in this study. The patients will
be treated with a single subconjunctival injection of 0.08 ml aflibercept (25 mg/ml) in a
single quarter of the conjunctiva, near the limbus in a proximity to the area of pathological
neovascularization.
During follow-up period, previous medical and ophthalmic history will be documented. On the
first visit, a thorough eye examination will be performed (including: Best Corrected Visual
Acuity (BCVA), slit lamp examination of anterior segment including fluorescein staining of
cornea for the assessment of epithelial integrity, intraocular pressure (IOP) measurements
with Goldman tonometry, and a specular microscopy examination). Follow-up examinations will
occur on days 7, 14, 30, 60, 90 following injection. Each follow-up meeting will include
documentation of BCVA, IOP, a slit lamp exam and specular microscopy exam. Investigators will
also perform anterior segment color photography before injection and at the last visit to
document regression of neovascularization.
If no improvement or partial improvement is noted on the 30th day follow-up, the cornea
specialist will consider a repeat subconjunctival aflibercept injection.
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