Comparison of Ranibizumab 0.5 mg Versus 1.0 mg for the Treatment of Patients With Clinically Significant Diabetic Macular Edema : A Randomized, Clinical Trial
Copyright 2016, SLACK Incorporated.
| Veröffentlicht in: | Ophthalmic surgery, lasers & imaging retina. - 2013. - 47(2016), 6 vom: 01. Juni, Seite 536-43 |
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| Format: | Online-Aufsatz |
| Sprache: | English |
| Veröffentlicht: |
2016
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| Zugriff auf das übergeordnete Werk: | Ophthalmic surgery, lasers & imaging retina |
| Schlagworte: | Clinical Trial, Phase I Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't Angiogenesis Inhibitors Ranibizumab ZL1R02VT79 |
| Zusammenfassung: | Copyright 2016, SLACK Incorporated. BACKGROUND AND OBJECTIVE: To compare ranibizumab (Lucentis; Genentech, South San Francisco, CA) 0.5 mg and 1.0 mg for the treatment of clinically significant diabetic macular edema (CSDME) PATIENTS AND METHODS: This was a 12-month, prospective, single-masked, randomized clinical trial. Patients with CSDME secondary to diabetic retinopathy were randomized to receive 0.5 mg or 1.0 mg of ranibizumab by intravitreal injection once monthly for 3 months and then once every other month as needed RESULTS: Patients received a mean of 6.5 injections in each group during the course of this 12-month study. The mean change in Early Treatment Diabetic Retinopathy Study visual acuity from baseline to month 12 was +3.8 letters in the ranibizumab 0.5-mg group (n = 23) and +7.9 letters in the 1.0-mg group (n = 23; P = .92 vs. 0.5 mg). Central foveal thickness (CFT) significantly decreased from baseline to month 12 in both dose groups CONCLUSION: Treatment of CSDME with ranibizumab resulted in a statistically significant improvement in visual acuity (ranibizumab 1.0 mg) and decrease in CFT and macular volume (ranibizumab 0.5 mg and 1.0 mg) from baseline to 12 months. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:536-543.] |
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| Beschreibung: | Date Completed 30.06.2017 Date Revised 01.12.2017 published: Print Citation Status MEDLINE |
| ISSN: | 2325-8179 |
| DOI: | 10.3928/23258160-20160601-05 |