Subconjunctival Aflibercept (EYLEA®) for the Treatment of Corneal Neovascularization

NCT02797704 | Terminated Phase 1

• 1 other identifier: 0134-16-RMC
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Regression (change from baseline) of neovascularization clinically assessed by a corneal specialist

  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.

  3 months (90 days), with repeat assessment at different follow up times at 7,14,30,60 and 90 days.

Secondary Outcomes (1)

• Best Corrected Visual Acuity (BCVA)

  3 months

Study Arms (1)

SC Aflibercept

EXPERIMENTAL

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

Interventions

Aflibercept DRUG

Eylea (aflibercept) Injection is a prescription medicine administered by injection into the eye.

Also known as: Eylea

SC Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Prior treatment for corneal neovascularization with the injection of Avastin/Lucentis.
• Patients under 18
• Pregnant women
• Contra indications for Eylea treatment, including intraocular or periocular infection/inflammation.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (14)

• Azar DT. Corneal angiogenic privilege: angiogenic and antiangiogenic factors in corneal avascularity, vasculogenesis, and wound healing (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2006;104:264-302.

  PMID: 17471348 BACKGROUND

• Stevenson W, Cheng SF, Dastjerdi MH, Ferrari G, Dana R. Corneal neovascularization and the utility of topical VEGF inhibition: ranibizumab (Lucentis) vs bevacizumab (Avastin). Ocul Surf. 2012 Apr;10(2):67-83. doi: 10.1016/j.jtos.2012.01.005. Epub 2012 Jan 25.

  PMID: 22482468 BACKGROUND

• Dastjerdi MH, Sadrai Z, Saban DR, Zhang Q, Dana R. Corneal penetration of topical and subconjunctival bevacizumab. Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8718-23. doi: 10.1167/iovs.11-7871.

  PMID: 22003112 BACKGROUND

• Chang JH, Garg NK, Lunde E, Han KY, Jain S, Azar DT. Corneal neovascularization: an anti-VEGF therapy review. Surv Ophthalmol. 2012 Sep;57(5):415-29. doi: 10.1016/j.survophthal.2012.01.007.

  PMID: 22898649 BACKGROUND

• Chang JH, Gabison EE, Kato T, Azar DT. Corneal neovascularization. Curr Opin Ophthalmol. 2001 Aug;12(4):242-9. doi: 10.1097/00055735-200108000-00002.

  PMID: 11507336 BACKGROUND

• Oliveira HB, Sakimoto T, Javier JA, Azar DT, Wiegand SJ, Jain S, Chang JH. VEGF Trap(R1R2) suppresses experimental corneal angiogenesis. Eur J Ophthalmol. 2010 Jan-Feb;20(1):48-54. doi: 10.1177/112067211002000106.

  PMID: 19882518 BACKGROUND

• Rocher N, Behar-Cohen F, Pournaras JA, Naud MC, Jeanny JC, Jonet L, Bourges JL. Effects of rat anti-VEGF antibody in a rat model of corneal graft rejection by topical and subconjunctival routes. Mol Vis. 2011 Jan 11;17:104-12.

  PMID: 21245949 BACKGROUND

• Semeraro F, Morescalchi F, Duse S, Parmeggiani F, Gambicorti E, Costagliola C. Aflibercept in wet AMD: specific role and optimal use. Drug Des Devel Ther. 2013 Aug 5;7:711-22. doi: 10.2147/DDDT.S40215. eCollection 2013.

  PMID: 23990705 BACKGROUND

• Dratviman-Storobinsky O, Avraham-Lubin BCR, Hasanreisoglu M, Goldenberg-Cohen N. Effect of subconjuctival and intraocular bevacizumab injection on angiogenic gene expression levels in a mouse model of corneal neovascularization. Mol Vis. 2009 Nov 13;15:2326-38.

  PMID: 19936307 RESULT

• Avisar I, Weinberger D, Kremer I. Effect of subconjunctival and intraocular bevacizumab injections on corneal neovascularization in a mouse model. Curr Eye Res. 2010 Feb;35(2):108-15. doi: 10.3109/02713680903429007.

  PMID: 20136420 RESULT

• Habot-Wilner Z, Barequet IS, Ivanir Y, Moisseiev J, Rosner M. The inhibitory effect of different concentrations of topical bevacizumab on corneal neovascularization. Acta Ophthalmol. 2010 Dec;88(8):862-7. doi: 10.1111/j.1755-3768.2009.01571.x.

  PMID: 19549103 RESULT

• Park YR, Chung SK. Inhibitory Effect of Topical Aflibercept on Corneal Neovascularization in Rabbits. Cornea. 2015 Oct;34(10):1303-7. doi: 10.1097/ICO.0000000000000507.

  PMID: 26114826 RESULT

• Sella R, Gal-Or O, Livny E, Dachbash M, Nisgav Y, Weinberger D, Livnat T, Bahar I. Efficacy of topical aflibercept versus topical bevacizumab for the prevention of corneal neovascularization in a rat model. Exp Eye Res. 2016 May;146:224-232. doi: 10.1016/j.exer.2016.03.021. Epub 2016 Mar 26.

  PMID: 27020759 RESULT

• Gal-Or O, Livny E, Sella R, Nisgav Y, Weinberger D, Livnat T, Bahar I. Efficacy of Subconjunctival Aflibercept Versus Bevacizumab for Prevention of Corneal Neovascularization in a Rat Model. Cornea. 2016 Jul;35(7):991-6. doi: 10.1097/ICO.0000000000000849.

  PMID: 27124775 RESULT

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Irit Bahar, MD

  Head of ophthalmology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 13, 2016
• Study Start: March 2, 2017
• Primary Completion: September 4, 2019
• Study Completion: September 10, 2019
• Last Updated: September 16, 2019

Record last verified: 2016-05

Locations

IL (1)