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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
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Corneal Neovascularization Drug: Aflibercept Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Aflibercept
Other Name: Eylea




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In this study, included will be patients with corneal neovascularization secondary to various pathologies, including: Pterygium, Corneal chemical burn, S/P corneal transplantation, Herpetic keratitis, atopic keratoconjunctivitis, Chronic retinal detachment, Uveitis, panus secondary to blepharitis, S/P corneal foreign body.

Exclusion Criteria:

  1. Patients with a history of retinal vein/artery occlusion or diabetes, currently treated with anti-VEGF or with a history of such treatment 3 months prior to enrollment.
  2. Prior treatment for corneal neovascularization with the injection of Avastin/Lucentis.
  3. Patients under 18
  4. Pregnant women
  5. Contra indications for Eylea treatment, including intraocular or periocular infection/inflammation.

Information from the National Library of Medicine

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


Contacts
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Contact: Eitan Livny, MD 0542127414 eitanlivny@gmail.com
Contact: Ruti Sella, MD 0525312871 rutibd@gmail.com

Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Irit Bahar, MD Head of Cornea

Publications of Results:
Other Publications:

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02797704     History of Changes
Other Study ID Numbers: 0134-16-RMC
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Neovascularization, Pathologic
Corneal Neovascularization
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases