Abstract | PURPOSE: DESIGN: Randomized, double-blind, multicenter, phase II clinical study. PARTICIPANTS AND CONTROLS: INTERVENTIONS: Four groups of 10 patients were treated for 3 months in this dose-finding study comparing 3 doses of GS-101 ( eye drops twice daily; 43, 86, and 172 microg/day total) with placebo (10 patients per group). MAIN OUTCOME MEASURES: The primary end point was the area covered by pathologic corneal blood vessels, which was measured morphometrically on digitized slit-lamp pictures using image analysis techniques. RESULTS:
GS-101 eye drops were well tolerated. All serious and 95% of all other adverse events were categorized by the investigators as unrelated. In 3 patients, there was a potentially related side effect of ocular surface discomfort. At a dose of 86 microg/day (43 microg/drop), GS-101 eye drops produced a significant inhibition and regression of corneal neovascularization (-2.04+/-1.57% of total corneal area; P = 0.0047), whereas the low dose tended to stabilize it (0.07+/-2.94%; P = 0.2088) compared with placebo (0.89+/-2.15%), where corneal neovascularization progressed in all patients. There was no apparent benefit to the higher dose (1.60+/-7.63%). CONCLUSIONS: The interim results of this phase II study suggest that GS-101 eye drops at an optimal dose of 86 microg/day are an effective and noninvasive approach specifically to inhibit and regress active corneal angiogenesis, a major risk factor for corneal graft transplantation and graft rejection. Safety concerns were not detected. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
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Authors | Claus Cursiefen, Felix Bock, Folkert K Horn, Friedrich E Kruse, Berthold Seitz, Vincent Borderie, Beatrice Früh, Michael A Thiel, Frank Wilhelm, Bernard Geudelin, Isabelle Descohand, Klaus-Peter Steuhl, Angela Hahn, Daniel Meller |
Journal | Ophthalmology
(Ophthalmology)
Vol. 116
Issue 9
Pg. 1630-7
(Sep 2009)
ISSN: 1549-4713 [Electronic] United States |
PMID | 19643487
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- GS 101
- Oligonucleotides
- Ophthalmic Solutions
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage, adverse effects)
- Corneal Neovascularization
(drug therapy, pathology)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Oligonucleotides
(administration & dosage, adverse effects)
- Ophthalmic Solutions
(administration & dosage, adverse effects)
- Treatment Outcome
- Visual Acuity
(drug effects)
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