Subconjunctival Aflibercept (EYLEA®) for the Treatment of Corneal Neovascularization
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|ClinicalTrials.gov Identifier: NCT02797704|
Recruitment Status : Unknown
Verified May 2016 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 13, 2016
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Corneal Neovascularization||Drug: Aflibercept||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: SC Aflibercept
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
Other Name: Eylea
- 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. ]Regression of corneal neovascularization as the change from baseline will be assessed at all follow-up times on days 7,14,30,60,90 following injection by the corneal specialist, both by a clinical slit lamp exam to evaluate the area of neovascularization from the entire corneal area (which will be determined clinically by the ophthalmologist), and by performing anterior segment color photography before injection and at the last visit for comparison and documentation purposes.
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 3 months ]BCVA will be assessed using a Snellen Chart at all follow-up meetings, and converted to logMAR for statistical analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797704
|Contact: Eitan Livny, MDfirstname.lastname@example.org|
|Contact: Ruti Sella, MDemail@example.com|
|Principal Investigator:||Irit Bahar, MD||Head of Cornea|