Felix Bock1, Mario Matthaei2, Thomas Reinhard3, Daniel Böhringer3, Jan Christoph4, Thomas Ganslandt4, Claus Cursiefen5. 1. Department of Ophthalmology, University of Cologne, Cologne, Germany; Cologne Ophthalmological Reading and Image Analysis Center (CORIC), University of Cologne, Cologne, Germany. 2. Department of Ophthalmology, University of Cologne, Cologne, Germany. 3. Department of Ophthalmology, University of Freiburg, Freiburg, Germany. 4. Institute of Medical Informatics, University of Erlangen, Erlangen, Germany. 5. 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.
Abstract
PURPOSE: To test whether subconjunctival cyclosporine A (CsA) implants affect the incidence and the degree of corneal neovascularizationoccurring 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 neovascularizationoccurring 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.
RCT Entities:
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 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.
Authors: Danial Roshandel; Medi Eslani; Alireza Baradaran-Rafii; Albert Y Cheung; Khaliq Kurji; Sayena Jabbehdari; Alejandra Maiz; Setareh Jalali; Ali R Djalilian; Edward J Holland Journal: Ocul Surf Date: 2018-06-20 Impact factor: 5.033
Authors: Lixia Luo; Jin Yang; Yumin Oh; Matthew J Hartsock; Shiyu Xia; Yoo-Chun Kim; Zheng Ding; Tuo Meng; Charles G Eberhart; Laura M Ensign; Jennifer E Thorne; Walter J Stark; Elia J Duh; Qingguo Xu; Justin Hanes Journal: J Control Release Date: 2019-01-17 Impact factor: 9.776