Comparison of 2-Year Outcomes between Intravitreal Ranibizumab and Intravitreal Aflibercept for Diabetic Macular Edema with "Treat-and-Extend" Regimen-Its Usefulness and Problems.

Published on Sep 2, 2020in Journal of Clinical Medicine3.303
· DOI :10.3390/JCM9092848
Shinichiro Chujo1
Estimated H-index: 1
(Mie University),
Masahiko Sugimoto14
Estimated H-index: 14
(Mie University)
+ 6 AuthorsMineo Kondo53
Estimated H-index: 53
(Mie University)
Background: To compare the effectiveness of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) performed with the treat-and-extend (TAE) regimen on eyes with diabetic macular edema (DME). Patients and methods: This is a retrospective study of 125 eyes of 125 treatment-naive DME patients who received anti-VEGF injections at three consecutive monthly intervals as the loading phase. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity scale (DRSS), and total injection numbers were compared between the two anti-VEGF agents. Results: Among 125 eyes, 26 eyes completed the treatment with the TAE regimen for 24 months (20.8%). Thirteen eyes of 13 patients (mean age, 70.9 ± 6.0 years) received intravitreal injections of 0.5 mg ranibizumab, and 13 eyes of 13 patients (65.9 ± 8.6 years) received 2 mg aflibercept. No significant differences were detected in the baseline demographics. At 24 months, BCVA was significantly improved in both groups; from 0.31 ± 0.19 to 0.10 ± 0.12 logMAR units for IVR and 0.41 ± 0.19 to 0.16 ± 0.28 logMAR units for IVA (p = 1.29 × 10−9). CRT was significantly reduced in both groups; 440.9 ± 69.3 to 307.5 ± 66.4 μm for IVR and 473.9 ± 71.5 to 317.8 ± 71.2 μm for IVA (p = 3.55 × 10−9). No significant differences were detected in the improvements of BCVA, CRT in both groups, and the total injection numbers for 24 months (11.0 ± 1.2 for the IVA group and 12.0 ± 1.0 the IVR group). DRSS was significantly improved in both groups (p = 0.0004 for IVR and p = 0.009 for IVA). Conclusion: No significant differences were detected in the improvements of BCVA or CRT and injection numbers between the IVR and IVA groups treated with the TAE regimen. These results indicate that the results of the treatment with both agents with the TAE regimen were equally effective, but only 20.8% of patients completed 24 months of continuous treatment with the TAE regimen. Synopsis: There are no significant differences regarding effectiveness between the IVR and IVA groups treated with the TAE regimen for DME eyes.
#1Masahiko Sugimoto (Mie University)H-Index: 14
#2Atushi Ichio (Mie University)H-Index: 2
Last. Mineo Kondo (Mie University)H-Index: 53
view all 7 authors...
Abstract Purpose To evaluate the effects of intravitreal aflibercept (IVA) on the microaneurysms (MAs) and sizes of non-perfused areas (NPAs) in eyes with diabetic macular edema (DME). Design Interventional, prospective study. Participants Twenty-five eyes of 25 DME patients (average age, 64.0±8.8 years) were treated with 3 consecutive monthly IVA injections. Methods Fluorescein angiography (FA) and optical coherence tomography were performed prior to the IVA injections(baseline) and at 1 week a...
6 CitationsSource
#1John F. PayneH-Index: 18
#2Charles C. Wykoff (Houston Methodist Hospital)H-Index: 41
Last. Daniel D. EsmailiH-Index: 2
view all 26 authors...
Purpose To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. Design This was a multicenter, randomized, clinical trial. Methods One hundred fifty eyes were randomized into 3 cohorts: monthly (n = 30), treat and extend without laser photocoagulation (TREX; n = 60), and treat and extend with angiography-guided laser photocoagulation (GILA; n = 60). Monthly cohort eyes received ranibizum...
18 CitationsSource
#1Masahiko Sugimoto (Mie University)H-Index: 14
#2Hideyuki Tsukitome (Mie University)H-Index: 4
Last. Taiji Sakamoto (Kadai: Kagoshima University)H-Index: 60
view all 20 authors...
AIMS/INTRODUCTION: To determine the current clinical preferences of anti-vascular endothelial growth factor (VEGF) treatment protocols for diabetic macular edema (DME) in Japan. MATERIALS AND METHODS: This was a descriptive cross-sectional study. Answers to a questionnaire consisting of 16 questions were obtained from 176 of 278 (63.3%) surveyed ophthalmologists. RESULTS: The results showed that 81.2% preferred intravitreal injections of anti-VEGF antibodies as the first-line therapy. The most i...
12 CitationsSource
#1Petra Schwarzer (University of Bern)H-Index: 2
#2Andreas Ebneter (University of Bern)H-Index: 20
Last. Martin S. Zinkernagel (University of Bern)H-Index: 25
view all 5 authors...
Purpose: To evaluate real-life outcomes in treatment-naive patients with diabetic macular edema (DME) treated with anti-vascular endothelial growth factor (VEGF) agents using a treat-and-extend regimen without a fixed loading phase. Methods: Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) measured using optical coherence tomography at baseline and after 1 year of treatment, intervals and number of injections were analyzed. Subgroup analysis was performed to compare anatom...
13 CitationsSource
#1Charles C. Wykoff (Cornell University)H-Index: 4
#2David A Eichenbaum (USF: University of South Florida)H-Index: 7
Last. Zdenka Haskova (Genentech)H-Index: 9
view all 6 authors...
Purpose To evaluate diabetic retinopathy (DR) outcomes with ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) treatment in patients with DR and diabetic macular edema (DME) at high risk of progression to proliferative disease. Design Post hoc analysis of the phase 3 RIDE ( identifier, NCT00473382 ) and RISE ( identifier, NCT00473330 ) clinical trials of ranibizumab for the treatment of DME. Participants Seven hundred forty-six patients with ba...
33 CitationsSource
#1Paul MitchellH-Index: 51
#2Ian L. McAllister (UWA: University of Western Australia)H-Index: 38
Last. Frank G. Holz (University of Bonn)H-Index: 88
view all 15 authors...
Purpose To evaluate the impact of intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Tarrytown, NY) versus laser on progression of diabetic retinopathy (DR) severity in Intravitreal Aflibercept Injection in Vision Impairment due to DME (VIVID-DME) and Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema (VISTA-DME). Design Secondary and exploratory analyses of 2 phase 3, randomized, controlled studies. Participants All patients with a baseline Diabetic Ret...
21 CitationsSource
#1Justis P. Ehlers (Cleveland Clinic)H-Index: 32
#2Kevin Wang (Case Western Reserve University)H-Index: 3
Last. Sunil K. Srivastava (Cleveland Clinic)H-Index: 34
view all 9 authors...
Purpose To assess the efficacy of ranibizumab for persistent diabetic macular edema (DME) previously treated with bevacizumab and compare monthly versus treat-and-extend (TREX) dosing. Design Twelve-month open-label prospective, randomized, comparative dosing study. Participants Twenty-seven participants with persistent foveal-involving DME recently treated with bevacizumab. Methods All participants were to receive 3 initial monthly 0.3-mg ranibizumab injections before randomization to monthly (...
10 CitationsSource
#1Masahiko SugimotoH-Index: 14
#2Atsushi IchioH-Index: 3
Last. Mineo KondoH-Index: 53
view all 4 authors...
To determine the efficacy of the treat and extend (TAE) protocol with intravitreal bevacizumab (IVB) for managing diabetic macular edema (DME). Retrospective, single-center study. For this retrospective study, 42 eyes of 42 patients were initially treated with 3 consecutive monthly IVB injections (loading phase), after which they were selected for different additional therapies. For the TAE protocol, the baseline treatment interval was selected to be 8 weeks and was sequentially lengthened by 2 ...
9 CitationsSource
#1Andreas Ebneter (University of Bern)H-Index: 20
#2Dominik Waldmeier (University of Bern)H-Index: 1
Last. Martin S. Zinkernagel (University of Bern)H-Index: 25
view all 5 authors...
Purpose To compare outcomes between an as-needed and a treat-and-extend regimen in managing diabetic macular edema with intravitreal ranibizumab.
9 CitationsSource
#1Atsuhiro Kanda (Hokkaido University)H-Index: 20
#2Kousuke Noda (Hokkaido University)H-Index: 39
Last. Susumu Ishida (Hokkaido University)H-Index: 52
view all 4 authors...
Vascular endothelial growth factor (VEGF)-A-driven angiogenesis contributes to various disorders including cancer and proliferative diabetic retinopathy (PDR). Among several VEGF-A blockers clinically used is aflibercept, a chimeric VEGFR1/VEGFR2-based decoy receptor fused to the Fc fragment of IgG1 (i.e., VEGFR1/VEGFR2-Fc). Here, we revealed a novel anti-angiogenic function for aflibercept beyond its antagonism against VEGF family members. Immunoprecipitation and mass spectrometry analyses iden...
40 CitationsSource
Cited By1
#1Yu Cheol Kim (KMU: Keimyung University)H-Index: 1
#2Jae Pil ShinH-Index: 17
Last. Ji Eun Lee (PNU: Pusan National University)H-Index: 19
view all 9 authors...
This study was performed to investigate the efficacy of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema (DME). This prospective, multicentre, interventional, single-arm, 104-week clinical trial included 48 patients with DME visual impairment. The patients' eyes received five consecutive intravitreal injections (2 mg aflibercept) every four weeks with two-week adjustments based on central subfield macular thickness (CSMT) changes. Injections were deferred when ...
2 CitationsSource