Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study
| Autor: | Steffen Schmitz-Valckenberg, Peter Wiedemann, Matus Rehak, Thomas Bertelmann, Gabriele E. Lang, Claudia Weiss, Nicolas Feltgen, Armin Wolf, Lars-Olof Hattenbach, Eva-Maria Paulus, Hüsnü Berk, Hans Hoerauf, Nicole Eter, Pankaj Puri, Amelie Pielen |
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| Rok vydání: | 2016 |
| Předmět: |
Male
Vascular Endothelial Growth Factor A Visual acuity genetic structures Health Status Visual Acuity Angiogenesis Inhibitors Dexamethasone Macular Edema law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Central retinal vein occlusion law Pro re nata Ranibizumab Retinal Vein Occlusion medicine Humans Glucocorticoids Macular edema Aged Drug Implants business.industry Middle Aged medicine.disease 3. Good health Europe Clinical trial Ophthalmology Anesthesia Intravitreal Injections Quality of Life 030221 ophthalmology & optometry Female medicine.symptom business Tomography Optical Coherence 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | American Journal of Ophthalmology. 169:258-267 |
| ISSN: | 0002-9394 |
| DOI: | 10.1016/j.ajo.2016.04.020 |
| Popis: | To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO).Phase IIIb, multicenter, double-masked, randomized clinical trial.Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs).Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P.0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%).Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported. |
| Databáze: | OpenAIRE |
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