High-dose subconjunctival cyclosporine a implants do not affect corneal neovascularization after high-risk keratoplasty.
OBJECTIVE
To test whether subconjunctival cyclosporine A (CsA) implants affect the incidence and the degree of corneal neovascularization occurring after penetrating keratoplasty.


METHODS
Prospective, randomized, multicenter, controlled phase 2/3 clinical trial. The study comprised 43 trial sites in Germany, India, and the United States.


METHODS
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.


METHODS
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 CellˆF 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.
Department of Ophthalmology, University of Cologne, Cologne, Germany; Cologne Ophthalmological Reading and Image Analysis Center (CORIC), University of Cologne, Cologne, Germany.
Felix
F
Bock
Department of Ophthalmology, University of Cologne, Cologne, Germany.
Mario
M
Matthaei
Department of Ophthalmology, University of Freiburg, Freiburg, Germany.
Thomas
T
Reinhard
Department of Ophthalmology, University of Freiburg, Freiburg, Germany.
Daniel
D
Böhringer
Institute of Medical Informatics, University of Erlangen, Erlangen, Germany.
Jan
J
Christoph
Institute of Medical Informatics, University of Erlangen, Erlangen, Germany.
Thomas
T
Ganslandt
Department of Ophthalmology, University of Cologne, Cologne, Germany; Cologne Ophthalmological Reading and Image Analysis Center (CORIC), University of Cologne, Cologne, Germany. Electronic address: claus.cursiefen@uk-koeln.de.
Claus
C
Cursiefen
D016510:Corneal Neovascularization / Q000188:drug therapy* / Q000453:epidemiology; D016572:Cyclosporine / Q000008:administration & dosage*; D004343:Drug Implants; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015994:Incidence; D007194:India / Q000453:epidemiology; D015948:Keratoplasty, Penetrating / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014481:United States / Q000453:epidemiology
D004343:Drug Implants; D007166:Immunosuppressive Agents; D016572:Cyclosporine