Abstract | OBJECTIVE: DESIGN: Multicenter, double-masked, randomized, placebo-controlled phase III study. PARTICIPANTS: MAIN OUTCOME MEASURES: RESULTS: Although no significant differences in VA scores between groups were observed, aganirsen significantly reduced the relative corneal neovascularization area after 90 days by 26.20% (P = 0.014). This improvement persisted after 180 days (26.67%, P = 0.012). Aganirsen tended to lower the transplantation need in the intent-to-treat (ITT) population at day 180 (P = 0.087). In patients with viral keratitis and central neovascularization, a significant reduction in transplantation need was achieved (P = 0.048). No significant differences between groups were observed in the risk of graft rejection. However, aganirsen tended to decrease this risk in patients with traumatic/viral keratitis (P = 0.162) at day 90. The QoL analyses revealed a significant improvement with aganirsen in composite and near activity subscores (P = 0.039 and 0.026, respectively) at day 90 in the per protocol population. Ocular and treatment-related treatment-emergent adverse events (TEAEs) were reported in a lower percentage with aganirsen compared with placebo. Only 3 serious TEAEs (2 with aganirsen and 1 with placebo) were considered treatment-related. CONCLUSIONS:
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Authors | Claus Cursiefen, Eric Viaud, Felix Bock, Bernard Geudelin, Antoine Ferry, Pavla Kadlecová, Michel Lévy, Salman Al Mahmood, Sylvie Colin, Eric Thorin, François Majo, Beatrice Frueh, Frank Wilhelm, Tobias Meyer-Ter-Vehn, Gerd Geerling, Daniel Böhringer, Thomas Reinhard, Daniel Meller, Uwe Pleyer, Björn Bachmann, Berthold Seitz |
Journal | Ophthalmology
(Ophthalmology)
Vol. 121
Issue 9
Pg. 1683-92
(Sep 2014)
ISSN: 1549-4713 [Electronic] United States |
PMID | 24811963
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Angiogenesis Inhibitors
- GS 101
- Oligonucleotides
- Oligonucleotides, Antisense
- Ophthalmic Solutions
|
Topics |
- Adult
- Aged
- Analysis of Variance
- Angiogenesis Inhibitors
(therapeutic use)
- Corneal Neovascularization
(drug therapy, etiology, surgery)
- Corneal Transplantation
- Double-Blind Method
- Female
- Graft Rejection
- Humans
- Keratitis
(complications)
- Male
- Middle Aged
- Oligonucleotides
(therapeutic use)
- Oligonucleotides, Antisense
(therapeutic use)
- Ophthalmic Solutions
- Quality of Life
- Visual Acuity
(drug effects)
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