Clinical Trial: Subconjunctival Aflibercept (EYLEA®) for the Treatment of Corneal Neovascularization
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title:
Brief Summary: 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.
Detailed Summary:
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
Sponsor: Rabin Medical Center
Current Primary Outcome: Regression (change from baseline) of neovascularization clinically assessed by a corneal specialist [ Time Frame: 3 months (90 days), with repeat assessment at different follow up times at 7,14,30,60 and 90 days. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Best Corrected Visual Acuity (BCVA) [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: May 24, 2016
Date Started: September 2016
Date Completion: June 2018
Last Updated: July 17, 2016
Last Verified: May 2016