CLINICAL EVALUATION OF PAZOPANIB EYE DROPS IN HEALTHY SUBJECTS AND IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
| Autor: | Trupti Trivedi, Rishi Singh, Linda S. Henderson, Li Ye, John I. Wurzelmann, Mohammad Hossain, Deborah S. Kelly |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Indazoles genetic structures Administration Topical Visual Acuity Biological Availability Angiogenesis Inhibitors Single Center Retina law.invention Pazopanib Young Adult Double-Blind Method Randomized controlled trial law Ophthalmology medicine Humans Tissue Distribution Young adult Aged Aged 80 and over Sulfonamides business.industry Healthy subjects General Medicine Middle Aged Protein-Tyrosine Kinases Macular degeneration medicine.disease Healthy Volunteers eye diseases Clinical trial Pyrimidines Receptors Vascular Endothelial Growth Factor Choroidal neovascularization Wet Macular Degeneration Female sense organs Ophthalmic Solutions medicine.symptom business medicine.drug |
| Zdroj: | Retina. 34:1787-1795 |
| ISSN: | 0275-004X |
| Popis: | To evaluate pazopanib 10 mg/mL eye drops (pazopanib) in healthy subjects and in subjects with previously untreated subfoveal choroidal neovascularization secondary to age-related macular degeneration.Study 1 (single center, randomized, placebo-controlled, double-masked) included 3 cohorts of 12 to 13 healthy subjects each who instilled pazopanib or placebo 4 times daily for 2 weeks. Study 2 (multicenter open-label) included 19 subjects with neovascular age-related macular degeneration who instilled pazopanib 4 times daily for 12 weeks. Both studies evaluated pharmacokinetics and safety. Study 2 also evaluated efficacy.Steady-state concentrations of pazopanib in plasma seemed to be reached by Week 2. At Week 4 (Study 2), there were no meaningful changes from baseline in the mean central retinal thickness (37.9 μm) or best-corrected visual acuity (0.1 letters) (primary endpoint), retinal morphology, choroidal neovascularization size, or total lesion size. Complement Factor H genotype had no effect on changes from baseline in the best-corrected visual acuity or central retinal thickness. The most common pazopanib-related ocular adverse events included eye irritation (Study 1, n = 7) and instillation site pain (Study 2, n = 3). No serious adverse events were reported.Pazopanib was well tolerated. In subjects with previously untreated neovascular age-related macular degeneration, pazopanib instilled 4 times daily as monothereapy did not seem to improve the best-corrected visual acuity or decrease the central retinal thickness. |
| Databáze: | OpenAIRE |
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