Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Diabetic Macular Edema (BRDME): The BRDME Study, a Randomized Trial

Autor: Vader, MJC, Schauwvlieghe, ASME, Verbraak, FD, Dijkman, G, Hooymans, JM, Los, LI, Zwinderman, AH, Peto, T, Hoyng, CB, van Leeuwen, R, Vingerling, Hans, Moll, AC, van Lith-Verhoeven, JJC, Dijkgraaf, MG, Schlingemann, RO
Přispěvatelé: Restoring Organ Function by Means of Regenerative Medicine (REGENERATE), W.J. Kolff Institute for Biomedical Engineering and Materials Science (KOLFF), Ophthalmology, ACS - Diabetes & metabolism, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, APH - Quality of Care, APH - Health Behaviors & Chronic Diseases
Rok vydání: 2020
Předmět:
Zdroj: Ophthalmology Retina, 4, 777-788
Ophthalmology. Retina, 4(8), 777-788. Elsevier
Vader, M J C, Schauwvlieghe, A S M E, Verbraak, F D, Dijkman, G, Hooymans, J M M, Los, L I, Zwinderman, A H, Peto, T, Hoyng, C B, van Leeuwen, R, Vingerling, J R, Moll, A C, van Lith-Verhoeven, J J C, Dijkgraaf, M G W, Schlingemann, R O & Bevacizumab and Ranibizumab in Diabetic Macular Edema Study Group 2020, ' Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Diabetic Macular Edema (BRDME) : The BRDME Study, a Randomized Trial ', Ophthalmology Retina, vol. 4, no. 8, pp. 777-788 . https://doi.org/10.1016/j.oret.2020.02.008
Ophthalmology Retina, 4, 8, pp. 777-788
Ophthalmology Retina, 4(8), 777-788. Elsevier Inc.
ISSN: 2468-7219
2468-6530
DOI: 10.1016/j.oret.2020.02.008
Popis: Contains fulltext : 225964.pdf (Publisher’s version ) (Open Access) PURPOSE: To generate conclusive evidence regarding the noninferiority of intravitreal bevacizumab compared with ranibizumab in patients with diabetic macular edema (DME). DESIGN: Comparative, randomized, double-masked, multicenter, noninferiority clinical trial. PARTICIPANTS: Eligible patients were older than 18 years, diagnosed with type 1 or type 2 diabetes mellitus, with glycosylated hemoglobin of less than 12%, central area thickness of more than 325 μm, and visual impairment from DME with a best-corrected visual acuity (BCVA) between 24 letters and 78 letters. METHODS: From June 2012 through February 2018, a total of 170 participants were randomized to receive 6 monthly injections of either 1.25 mg bevacizumab (n = 86) or 0.5 mg ranibizumab (n = 84). MAIN OUTCOME MEASURES: Primary outcome was change in BCVA from baseline to month 6 compared between the 2 treatment arms. The noninferiority margin was 3.5 letters. RESULTS: The difference in mean BCVA between treatment arms was 1.8 letters in favor of ranibizumab after 6 months of follow-up; BCVA improved by 4.9±6.7 letters in the bevacizumab group and 6.7±8.7 letters in the ranibizumab group. The lower bound of the 2-sided 90% confidence interval (CI) was -3.626 letters, exceeding the noninferiority margin of 3.5 letters. Central area thickness decreased more with ranibizumab (138.2±114.3 μm) compared with bevacizumab (64.2±104.2 μm). In a post hoc subgroup analysis, participants with a worse BCVA at baseline (≤69 letters) improved by 6.7±7.0 letters with bevacizumab and 10.4±10.0 letters with ranibizumab, and central area thickness decreased significantly more in the ranibizumab arm of this subgroup compared with the bevacizumab arm. Participants with an initially better BCVA at baseline (≥70 letters) did not demonstrate differences in BCVA or OCT outcomes between treatment arms. CONCLUSIONS: Based on change in BCVA from baseline to month 6, the noninferiority of 1.25 mg bevacizumab to 0.5 mg ranibizumab was not confirmed. Only the subgroup of patients with a lower BCVA at baseline showed better visual acuity and anatomic outcomes with ranibizumab. Our study confirmed the potential differential efficacy of anti-vascular endothelial growth factor agents in the treatment of DME as well as the difference in response between patient groups with different baseline visual acuities.
Databáze: OpenAIRE
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