scholarly journals Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study

2020 ◽  
Vol 258 (3) ◽  
pp. 521-528 ◽  
Author(s):  
Jean-François Korobelnik ◽  
Vincent Daien ◽  
Céline Faure ◽  
Ramin Tadayoni ◽  
Audrey Giocanti-Auregan ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Treatment Start ◽  
Anti Vegf ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Endothelial Growth Factor

Abstract Purpose To report the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema (DME) in French clinical practice. Methods APOLLON (NCT02924311) was a prospective, observational cohort study of patients with DME. Effectiveness was evaluated by change from baseline in best-corrected visual acuity (BCVA) at 12 months in treatment-naïve patients (i.e., had not received any anti-vascular endothelial growth factor [anti-VEGF] agent, laser, or steroid at IVT-AFL treatment start) and previously treated patients (i.e., previously treated with anti-VEGF agents other than IVT-AFL, laser, or steroids at IVT-AFL treatment start). Secondary endpoints included change in central retinal thickness (CRT) over 12 months, frequency of injections, and proportion of patients with safety events. Results Of the 147 patients followed for at least 12 months and included in the effectiveness analysis, 52.4% (n = 77) were treatment-naïve and 47.6% (n = 70) were previously treated. Mean (standard deviation [SD]) BCVA score at baseline was 62.7 (14.3) Early Treatment Diabetic Retinopathy Study (ETDRS) letters in treatment-naïve patients and 60.0 (13.7) ETDRS letters in previously treated patients. At month 12, mean (SD) change in BCVA was + 7.8 (12.3) letters in treatment-naïve patients and + 5.0 (11.3) letters in previously treated patients. Mean CRT decreased in both patient cohorts. The mean (SD) number of IVT-AFL injections at month 12 was 7.6 (2.5) for treatment-naïve patients and 7.6 (2.3) for previously treated patients. Of 388 patients included in the safety analysis, ocular treatment-emergent adverse events occurred in 54.1% (n = 210) of patients. Conclusion IVT-AFL treatment was associated with improvements in functional and anatomic outcomes in both treatment-naïve and previously treated patients with DME in France.

scholarly journals Comparison of outcomes between intravitreal ranibizumab and intravitreal aflibercept for diabetic macular edema with “Treat-and-Extend” regimen

2020 ◽  
Author(s):  
Masahiko Sugimoto ◽  
Shinichiro Chujo ◽  
Taku Sasaki ◽  
Atsushi Ichio ◽  
Ryohei Miyata ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Retinal Thickness ◽  
Intravitreal Ranibizumab ◽  
Treat And Extend ◽  
Corrected Visual Acuity ◽  
Anti Vegf ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Treat And Extend Regimen

Abstract 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 was a retrospective study of 125 eyes of 125 treatment naïve DME patients who received anti-VEGF injections at 3 consecutive monthly intervals as the loading phase. Of these 125 eyes, 26 eyes completed the treatment with the TAE regimen for at least 24 months. Among the 26 eyes, 13 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. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity (DRS), and total injection numbers were compared between the two anti-VEGF agents.Results No significant differences were detected in the baseline demographics. At 24 months, the 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=1.29x10 -9 ). The 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=3.55x10 -9 ). No significant differences were detected in the improvements of the BCVA and the CRT in both groups, and the total injection numbers were significant fewer for the IVA group (11.0±1.2) than the IVR group (12.0±1.0). The DRS 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 the BCVA or CRT and injection numbers between 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.

scholarly journals Comparison of 2-Year Outcomes between Intravitreal Ranibizumab and Intravitreal Aflibercept for Diabetic Macular Edema with “Treat-and-Extend” Regimen—Its Usefulness and Problems

2020 ◽  
Vol 9 (9) ◽  
pp. 2848
Author(s):  
Shinichiro Chujo ◽  
Masahiko Sugimoto ◽  
Taku Sasaki ◽  
Yoshitsugu Matsui ◽  
Kumiko Kato ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Continuous Treatment ◽  
Intravitreal Ranibizumab ◽  
Treat And Extend ◽  
Corrected Visual Acuity ◽  
Anti Vegf ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Treat And Extend Regimen

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-naïve 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.

scholarly journals Adjunct Intravitreous Triamcinolone Acetonide in the Treatment of Diabetic Macular Edema with Anti-VEGF Agents

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Robert B. Garoon ◽  
Robert E. Coffee ◽  
Lai Jiang ◽  
Christina Y. Weng ◽  
Petros E. Carvounis
Keyword(s):  
Macular Edema ◽  
Triamcinolone Acetonide ◽  
Diabetic Macular Edema ◽  
Anti Vegf ◽  
Treatment Naïve ◽  
The Mean ◽  
Group 2 ◽  
Endothelial Growth Factor ◽  
Phakic Eyes ◽  
Group 1

Aims.To compare visual and anatomic outcomes of adjunct intravitreous (IVT) triamcinolone acetonide to antivascular endothelial growth factor (VEGF) injections to IVT anti-VEGF injections alone for center-involving diabetic macular edema (DME) in treatment-naïve eyes.Methods.Retrospective study of treatment-naïve eyes with center-involving DME. The primary outcome was the change in best corrected visual acuity (BCVA) in eyes receiving only IVT anti-VEGF (group 1) and eyes receiving IVT anti-VEGF and adjunct IVT-TA (group 2).Results.Included were 192 eyes. The mean change in BCVA was +3.5 letters in group 1 compared to −3.5 letters in group 2 (p=0.048). Final macular thickness improved by −94 μm in group 1 versus −68 μm in group 2 (p=0.26). In group 1, 5/150 eyes compared to 9/42 eyes in group 2 (3.3% versus 21%,p=0.0005) had a IOP >10 mmHg increase. Six of 126 phakic eyes in group 1 versus 12/33 phakic eyes in group 2 underwent cataract surgery (4.7% versus 36.3%,p=0.00009).Conclusions.IVT-TA results in no additional benefit in eyes treated with anti-VEGF agents for DME.

Evaluation of Patients Receiving Intravitreal Antivascular Endothelial Growth Factor for Diabetic Macular Edema in Clinical Practice in the United States

2020 ◽  
pp. 247412642095306
Author(s):  
John D. Pitcher ◽  
Andrew A. Moshfeghi ◽  
Genevieve Lucas ◽  
Nick Boucher ◽  
Hadi Moini ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Growth Factor ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
The United States ◽  
Treatment Frequency ◽  
Anti Vegf ◽  
Injection Frequency ◽  
Antivascular Endothelial Growth Factor ◽  
Endothelial Growth Factor

Purpose: We assessed the effect of treatment frequency with intravitreal antivascular endothelial growth factor (anti-VEGF) agents on visual acuity (VA) in diabetic macular edema (DME). Methods: This retrospective analysis assessed electronic medical records of eyes newly diagnosed with DME and treated with an anti-VEGF agent at US clinics using the Vestrum Health (Naperville, Illinois) treatment and outcomes database. Eyes were divided into 2 injection frequency subcohorts (≤ 6 vs > 6 injections/y); treatment frequency and change in mean VA (Early Treatment Diabetic Retinopathy Study letters) were evaluated. Results: Among 155 240 eyes assessed, 3028 met inclusion criteria for analysis in year 1 and 1292 in year 2. During year 1 of treatment, 57% (n = 1725) received > 6 injections; most continued to receive the same injection frequency during year 2. Mean VA gain from baseline at year 1 was lower in the ≤ 6 than in the > 6 injections/year subcohort (3.7 vs 8.0 letters, respectively; P < .001). Mean VA change from the end of year 1 to year 2 for eyes receiving ≤ 6 injections in year 1 generally remained unchanged, irrespective of year 2 dosing frequency. In eyes that received > 6 injections in year 1, mean VA loss was significantly greater for eyes receiving less-frequent dosing in year 2 than in those maintained on > 6 injections. Conclusions: More than 50% of eyes with DME in routine clinical practice that completed at least 1 year of follow-up received > 6 injections of an anti-VEGF agent during the first year, resulting in better VA gains than eyes treated less frequently.

scholarly journals The Impact of Interval between Recurrence and Reinjection in Anti-VEGF Therapy for Diabetic Macular Edema in Pro Re Nata Regimen

2021 ◽  
Vol 10 (24) ◽  
pp. 5738
Author(s):  
Yoshihiro Takamura ◽  
Teruyo Kida ◽  
Hidetaka Noma ◽  
Makoto Inoue ◽  
Shigeo Yoshida ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Functional Improvement ◽  
Vascular Endothelial ◽  
Anti Vegf ◽  
Group 3 ◽  
Pro Re Nata ◽  
Endothelial Growth Factor ◽  
The Impact ◽  
Deferred Group

Background: Pro re nata (PRN) regimen using anti-vascular endothelial growth factor (VEGF) agent is popular for the treatment of diabetic macular edema (DME). We investigated the influence of waiting time (WT) and interval between the date of recurrence of edema and re-injection on treatment efficacy. Methods: This retrospective study conducted at 7 sites in Japan enrolled patients who received intravitreal injection of ranibizumab (IVR) and aflibercept (IVA) in 1+PRN regimen. Enrolled patients were divided into 2 groups: prompt group (less than 1 week) and deferred group (3 weeks or more). Central retinal thickness (CRT) and best corrected visual acuity (BCVA) were measured every month for 1 year. Results: CRT in the deferred group was significantly higher than that in the prompt group at 2, 5, 6, 7, and 12 months (p < 0.05). BCVA in the prompt group was significantly better than that in the deferred group at 7, 10, and 12 months (p < 0.05). Conclusion: The prompt group was superior in anatomical and functional improvement of DME in anti-VEGF therapy than the deferred group. Our data suggests that shorter WT is recommended for better visual prognosis in the treatment for DME.

scholarly journals Combination Treatment of Diabetic Macular Edema with Anti-Vascular Endothelial Growth Factor and Steroids: Analysis of DRCR.net Protocol U

2018 ◽  
Vol 1 ◽  
pp. 2
Author(s):  
Cindy Ung ◽  
Kareem Moussa ◽  
Yoshihiro Yonekawa
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Diabetic Patients ◽  
Vascular Endothelial ◽  
First Line ◽  
Second Line Therapy ◽  
Anti Vegf ◽  
Endothelial Growth Factor

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients. Intravitreal anti-vascular endothelial growth factor (VEGF) therapy is considered the first-line treatment option in the management of DME with corticosteroids used as second-line therapy. The DRCR.net Protocol U study was a Phase II trial that sought to compare the combination of a steroid and anti-VEGF therapy to anti-VEGF monotherapy regarding visual acuity and anatomic outcomes. This review highlights the strengths, weaknesses, and clinical implications of this study.

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