Universität zu Köln

Bock, Felix, Matthaei, Mario, Reinhard, Thomas, Boehringer, Daniel, Christoph, Jan, Ganslandt, Thomas ORCID: 0000-0001-6864-8936 and Cursiefen, Claus (2014). High-Dose Subconjunctival Cyclosporine A Implants Do Not Affect Corneal Neovascularization after High-Risk Keratoplasty. Ophthalmology, 121 (9). S. 1677 - 1683. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1549-4713

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Abstract

Purpose: To test whether subconjunctival cyclosporine A (CsA) implants affect the incidence and the degree of corneal neovascularization occurring after penetrating keratoplasty. Design: Prospective, randomized, multicenter, controlled phase 2/3 clinical trial. The study comprised 43 trial sites in Germany, India, and the United States. Participants: Enrolled patients (n = 97) were randomized to 1 of 3 groups: treatment group A (n = 36), treatment group B (n = 40), and the control group (n = 21). Methods: Patients from each group received either of 2 doses of subconjunctival CsA (group A, low-dose CsA; group B, high-dose CsA) or placebo (carrier only) implants at the time of high-risk penetrating keratoplasty. Main Outcome Measures: The incidence and degree of corneal neovascularization occurring after penetrating keratoplasty were evaluated in a substudy (LX201-01 study: NCT00447187). A web-based image upload system was developed. Standardized digital slit-lamp pictures were quantitatively and objectively evaluated using Cell. F morphometry software. Results: No statistically significant difference in incidence and degree of corneal neovascularization developing after penetrating keratoplasty was found between treatment groups and placebo group. Mean corneal neovascularization area at week 52 (visit 12) was 2.32 +/- 1.79% in treatment group A versus placebo (2.79 +/- 2.11%; P = 0.45) and 2.74 +/- 2.22% in treatment group B versus placebo (2.79 +/- 2.11%; P = 0.94). Conclusions: High-dose subconjunctival CsA implants do not significantly affect corneal neovascularization after high-risk penetrating keratoplasty. This suggests that local CsA has negligible antiangiogenic effects in the human cornea, at least in the transplant setting. (C) 2014 by the American Academy of Ophthalmology.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bock, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Matthaei, Mario UNSPECIFIED UNSPECIFIED UNSPECIFIED Reinhard, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Boehringer, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Christoph, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Ganslandt, Thomas UNSPECIFIED orcid.org/0000-0001-6864-8936 UNSPECIFIED Cursiefen, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-430317
DOI:	10.1016/j.ophtha.2014.03.016
Journal or Publication Title:	Ophthalmology
Volume:	121
Number:	9
Page Range:	S. 1677 - 1683
Date:	2014
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1549-4713
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ENDOTHELIAL GROWTH-FACTOR; IMPROVES GRAFT-SURVIVAL; PENETRATING KERATOPLASTY; SYSTEMIC CYCLOSPORINE; INFLAMMATORY NEOVASCULARIZATION; MYCOPHENOLATE-MOFETIL; LYMPHATIC VESSELS; CLINICAL-TRIAL; BLOOD-VESSELS; LYMPHANGIOGENESIS Multiple languages Ophthalmology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43031