Academic Journal
An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema
| العنوان: | An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema |
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| المؤلفون: | Do, D V, Nguyen, Q D, Shah, S M, Browning, D J, Haller, J A, Chu, K, Yang, K, Cedarbaum, J M, Vitti, R L, Ingerman, A, Campochiaro, P A |
| بيانات النشر: | British Medical Journal Publishing Group |
| سنة النشر: | 2009 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Original articles - Clinical science |
| الوصف: | Aim: The aim of the study was to assess the safety and bioactivity of a single intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye in subjects with diabetic macular oedema (DMO). Methods: Five subjects with DMO, foveal thickness ⩾250 μm measured by optical coherence tomography (OCT), and best-corrected visual acuity (BCVA) between 20/40 and 20/320, were enrolled. Each participant received a single intravitreal injection of 4.0 mg of VEGF Trap-Eye followed by a 6-week observation period. Outcome measures included safety and biological activity, including changes in BCVA and excess retinal thickness assessed by OCT. Results: Injections of VEGF Trap-Eye were well tolerated with no ocular toxicity. One patient had an unrelated serious adverse event: hospitalisation for cellulitis of the left foot 27 days after injection of VEGF Trap-Eye. Median baseline BCVA was 36 ETDRS letters read at 4 m (not ETDRS visual acuity score; Snellen equivalent: 20/50) and median baseline excess central 1 mm foveal thickness (FTH) was 108 μm. At 4 weeks after injection, the median excess FTH was 59 μm and the median improvement in BCVA was nine letters. At 6 weeks after injection, four of the five patients showed improvement in excess FTH (median 74 μm; 31% reduction from baseline, p = 0.0625) and four of the five showed improvement in BCVA (median improvement of three letters). Conclusions: A single intravitreal injection of 4.0 mg of VEGF Trap-Eye was well tolerated and preliminary evidence of bioactivity was detected. These findings support additional studies investigating multiple injections of VEGF Trap-Eye in patients with DMO. |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| Relation: | http://bjo.bmj.com/cgi/content/short/93/2/144; http://dx.doi.org/10.1136/bjo.2008.138271 |
| DOI: | 10.1136/bjo.2008.138271 |
| الاتاحة: | http://bjo.bmj.com/cgi/content/short/93/2/144 https://doi.org/10.1136/bjo.2008.138271 |
| Rights: | Copyright (C) 2009, BMJ Publishing Group Ltd |
| رقم الانضمام: | edsbas.212F5B1E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/bjo.2008.138271 |
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