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

Bevacizumab and Ranibizumab in Diabetic Macular Edema Study Group, Maartje J C Vader, Ann-Sofie M E Schauwvlieghe, Frank D Verbraak, Greetje Dijkman, Johanna M M Hooymans, Leonoor I Los, Aeilko H Zwinderman, Tunde Peto, Carel B Hoyng, Redmer van Leeuwen, Johannes R Vingerling, Annette C Moll, Janneke J C van Lith-Verhoeven, Marcel G W Dijkgraaf, Reinier O Schlingemann*

*Bijbehorende auteur voor dit werk

OnderzoeksoutputAcademic

1 Citaat (Scopus)
15 Downloads (Pure)

Samenvatting

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.

Originele taal-2English
Pagina's (van-tot)777-788
Aantal pagina's12
TijdschriftOphthalmology. Retina
Volume4
Nummer van het tijdschrift8
DOI's
StatusPublished - aug-2020

Citeer dit