scholarly journals Two-year outcomes of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Yu Cheol Kim ◽  
Jae Pil Shin ◽  
Kang Yeun Pak ◽  
Hyun Woong Kim ◽  
Min Sagong ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Treat And Extend ◽  
Scale Scores ◽  
Dosing Regimens ◽  
Injection Interval ◽  
Flexible Dosing ◽  
The Mean ◽  
Number Of Injections ◽  
Treat And Extend Regimen

AbstractThis 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 CSMT was stable. The number of injections, best-corrected visual acuity (BCVA), CSMT, and diabetic retinopathy severity scale scores were analysed. Compared to baseline, BCVA improved by + 9.1 letters at 52 weeks and was maintained with + 9.4-letter gain at 104 weeks (P < 0.001). Between baseline and 104 weeks, CSMT decreased from 489 to 298 μm (P < 0.001) and eyes with vision ≥ 20/40 increased from 17.4 to 43.5% (P = 0.007). The mean number of injections decreased from 8.5 in year one to 3.9 in year two. The injection interval was extended to ≥ 12 weeks in 56.5% of patients. The treat-and-extend regimen of aflibercept in DME showed 2-year efficacy comparable to that of fixed dosing regimens. The flexible dosing of this regimen reduced the number of injections in year two while maintaining efficacy.

scholarly journals Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Takao Hirano ◽  
Yuichi Toriyama ◽  
Yoshihiro Takamura ◽  
Masahiko Sugimoto ◽  
Taiji Nagaoka ◽  
...  
Keyword(s):  
Open Label ◽  
Treat And Extend ◽  
Corrected Visual Acuity ◽  
Treatment Interval ◽  
Primary Endpoints ◽  
Intravitreal Aflibercept ◽  
Injection Interval ◽  
The Mean ◽  
Treat And Extend Regimen

AbstractThis prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8–16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.

scholarly journals Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study

2015 ◽  
Vol 100 (6) ◽  
pp. 787-795 ◽  
Author(s):  
Christian Prünte ◽  
Franck Fajnkuchen ◽  
Sajjad Mahmood ◽  
Federico Ricci ◽  
Katja Hatz ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Treat And Extend ◽  
Treat And Extend Regimen

One-year real-life results on effect of intravitreal aflibercept in patients with diabetic macular oedema switched from ranibizumab

2020 ◽  
pp. 112067212092727
Author(s):  
Marko Lukic ◽  
Gwyn Williams ◽  
Zaid Shalchi ◽  
Praveen J Patel ◽  
Philip G Hykin ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Diabetic Retinopathy ◽  
Early Treatment ◽  
Macular Oedema ◽  
Real Life ◽  
Diabetic Macular Oedema ◽  
Foveal Thickness ◽  
Macular Volume ◽  
Central Foveal Thickness ◽  
The Mean

Purpose To assess visual and optical coherence tomography–derived anatomical outcomes of treatment with intravitreal aflibercept (Eylea®) for diabetic macular oedema in patients switched from intravitreal ranibizumab (Lucentis®). Design Retrospective, cohort study. Participants Ninety eyes (of 67 patients) receiving intravitreal anti–vascular endothelial growth factor therapy were included. Methods This is a retrospective, real-life, cohort study. Each patient had visual acuity measurements and optical coherence tomography scans performed at baseline and 12 months after the first injection of aflibercept was given. Main Outcome Measures We measured visual acuities in Early Treatment Diabetic Retinopathy Study letters, central foveal thickness and macular volume at baseline and at 12 months after the first aflibercept injection was given. Results Ninety switched eyes were included in this study. The mean (standard deviation) visual acuity was 63 (15.78) Early Treatment Diabetic Retinopathy Study letters. At baseline, the mean (standard deviation) central foveal thickness was 417.7 (158.4) μm and the mean macular volume was 9.96 (2.44) mm3. Mean change in visual acuity was +4 Early Treatment Diabetic Retinopathy Study letters (p = 0.0053). The mean change in macular volume was −1.53 mm 3 in SW group (p = 0.21), while the change in central foveal thickness was −136.8 μm (p = 0.69). Conclusion There was a significant improvement in visual acuity and in anatomical outcomes in the switched group at 12 months after commencing treatment with aflibercept for diabetic macular oedema.

scholarly journals HbA1c as a predictor for response of bevacizumab in diabetic macular oedema

2020 ◽  
Vol 5 (1) ◽  
pp. e000449
Author(s):  
Sadhana Sharma ◽  
Sagun Narayan Joshi ◽  
Pratap Karki
Keyword(s):  
Glycaemic Control ◽  
Macular Oedema ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Intravitreal Bevacizumab ◽  
Glycosylated Haemoglobin ◽  
Baseline Hba1c ◽  
Good Glycaemic Control ◽  
The Mean ◽  
Study Participants

ObjectiveTo study the influence of glycosylated haemoglobin (HbA1c) on response of bevacizumab in patients with diabetic macular oedema.Methods and AnalysisA total of 37 eyes of 37 patients with vision loss due to diabetic macular oedema treated with bevacizumab were included in this study. Participants received monthly intravitreal bevacizumab (0.05 mL/1.25 mg) for 3 months.ResultsThere were 17 patients with baseline HbA1c ≤7% (<53mmol/mol) and 20 patients with baseline HbA1c >7% (>53mmol/mol) treated with bevacizumab included in the study. The mean improvement in visual acuity at 3 months was 0.50 logMAR in HbA1c ≤7%(<53mmol/mol) group and 0.33 logMAR in HbA1c >7%(>53mmol/mol) group (95% CI,-0.05-0.38; p=0.13). The mean central macular thickness (CMT) reduction was −229.76 µm in patients with a baseline HbA1c ≤7% (<53 mmol/mol) and −145.20 µm in patients with HbA1c of >7% (>53mmol/mol) (95% CI,12.98-156.14; p=0.022).ConclusionOur study suggests that baseline glycaemic control can affect the treatment outcome of intravitreal bevacizumab in the management of diabetic macular oedema and the response was found to be better in patients with good glycaemic control (low HbA1c).

scholarly journals Two-year outcomes of intravitreal aflibercept in a Swiss routine treat and extend regimen for patients with neovascular age-related macular degeneration

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Andreas Ebneter ◽  
Stephan Michels ◽  
Christian Pruente ◽  
Pascal Imesch ◽  
Felix Eilenberger ◽  
...  
Keyword(s):  
Real Life ◽  
Age Related Macular Degeneration ◽  
Routine Practice ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
The Mean ◽  
Treat And Extend Regimen

AbstractThe aim of this observational study was to assess the use and outcome of intravitreal aflibercept in a treat and extend regimen in treatment-naïve neovascular AMD patients in routine practice. This both retrospective and prospective study was conducted in four larger Swiss retina clinics (ASTERIA study). The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in ETDRS letters from baseline to 12 months. Between December 2017 and August 2018, 160 patients were included. For patients with available data, the mean change in BCVA was + 8.4 (± 14.4) letters at month 12 (n = 139) and + 5.0 (± 11.4) letters at month 24 (n = 95). A mean number of 8.3 (± 2.4) injections were administered within the first year and 5.4 (± 2.9) injections during the second year. On average, the observed treatment interval at month 12 was 63.3 (± 22.0) days and increased to 69.1 (± 28.6) days at month 24. For 37% of the patients, a treatment interval ≥ 12 weeks was attained at month 24. In conclusion,  intravitreal aflibercept in a Swiss real-life treat and extend regimen resulted in comparable anatomic and functional outcomes as were observed in the prospective registration trials of aflibercept for nAMD treatment.

Hyperreflective cystoid spaces in diabetic macular oedema: prevalence and clinical implications

2020 ◽  
pp. bjophthalmol-2020-317191
Author(s):  
Aude Couturier ◽  
Valerie Mane ◽  
Carlo Alessandro Lavia ◽  
Ramin Tadayoni
Keyword(s):  
Macular Oedema ◽  
Optical Coherence Tomography Angiography ◽  
Diabetic Macular Oedema ◽  
Functional Improvement ◽  
Vascular Endothelial ◽  
Hard Exudates ◽  
Corrected Visual Acuity ◽  
The Mean ◽  
Endothelial Growth Factor

AimsTo analyse the prevalence and evolution of hyper-reflective cystoid spaces with decorrelation signal detected using optical coherence tomography angiography (OCTA) in diabetic macular oedema (DMO).MethodsA retrospective study of consecutive eyes with DMO imaged using OCTA over a 1-year period was conducted. All eyes with hyper-reflective cystoid spaces at baseline and at least 3 months of follow-up were included in a longitudinal analysis.ResultsThe prevalence of hyperreflective cystoid spaces with decorrelation signal was of 37% (61/165) in DMO eyes. Hyperreflective foci within hyperreflective cystoid spaces were observed in 85% of eyes. The longitudinal study included 33 eyes (10 observed and 23 treated with intravitreal anti-vascular endothelial growth factor), with a median follow-up of 15 months. The hyperreflective cystoid spaces resolved in 85% of eyes. The mean best-corrected visual acuity remained stable during the follow-up, even in the eyes achieving a resolution of the hyperreflective cystoid spaces. Hard exudates appeared in the area of resolved hyperreflective cystoid spaces in 33% of eyes.ConclusionHyperreflective cystoid spaces detected by OCTA affected more than one-third of the DMO eyes. Their disappearance was not associated with any functional improvement and led to the formation of new hard exudate deposits in about one-third of the eyes.

scholarly journals Evaluation of 0.2 µg/day fluocinolone acetonide (ILUVIEN) implant in a cohort of previously treated patients with diabetic macular oedema (DMO): a 36-month follow-up clinical case series

2020 ◽  
Vol 5 (1) ◽  
pp. e000484
Author(s):  
Muna Ahmed ◽  
Christine Putri ◽  
Hibba Quhill ◽  
Fahd Quhill
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Macular Oedema ◽  
Case Series ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
The Mean

ObjectiveTo assess the real-world effectiveness and safety of single injection of a fluocinolone acetonide (FAc) implant in previously treated patients with recurrent diabetic macular oedema (DMO) over a 36-month follow-up period.Methods and AnalysisThis is a retrospective study conducted at a single ophthalmology department at the Royal Hallamshire Hospital, Sheffield, UK. Data were collected using electronic medical records to identify all patients treated with a FAc implant for DMO between March 2014 and November 2014, followed with a 36-month clinic follow-up. Outcomes measured included mean change in best-recorded visual acuity (BRVA) and central macular thickness (CMT) over the period of 36 months, treatment burden pre-implant and post-implant, and functional and anatomical responder rates.ResultsTwenty-six eyes (n=22 patients) were treated with single intravitreal FAc implant followed with 36 months of follow-up. At 24 and 36 months, 86.4% and 75.0% of patients maintained or gained vision post-FAc implant in routine clinical practice. The mean BRVA increased from 41.8 to 54.6 letters at month 24 and 45.8 letters at month 36, with 50.0% and 33.3% of patients achieving a ≥15 letter improvement at months 24 and 36, respectively. The mean CMT reduced from 600.8 µm at baseline to 351.0 µm and 392.5 µm at months 24 and 36, respectively. Overall, a mean of one treatment every 13.33 months post-FAc implant (vs 3.24 months pre-FAc implant) was reported. Eleven eyes had an increased intraocular pressure of ≥10 mm Hg and 12 eyes had an increase to ≥25 mm Hg from baseline.ConclusionThese results further support the effectiveness and safety of FAc implant in previously treated patients with persistent or recurrent DMO in a real-world clinical practice.

Long-term outcomes with as-needed aflibercept in diabetic macular oedema: 2-year outcomes of the ENDURANCE extension study

2017 ◽  
Vol 102 (5) ◽  
pp. 631-636 ◽  
Author(s):  
Charles C Wykoff ◽  
William C Ou ◽  
Rahul N Khurana ◽  
David M Brown ◽  
W Lloyd Clark ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Phase Iii ◽  
Extension Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Intravitreal Aflibercept ◽  
The Mean

Background/aimsTo evaluate the efficacy and safety of individualised 2.0 mg intravitreal aflibercept retreatment for diabetic macular oedema (DME) through the fifth year of management.MethodsThis is a phase IV, 2-year, open-label extension study. Sixty patients completing the 3-year VISTA DME (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) phase III trial enrolled in the ENDURANCE (Long-Term Efficacy and Safety of Intravitreal Aflibercept for the Treatment of DME in Subjects Who Completed the VISTA DME Trial) extension study. All patients received aflibercept in the presence of clinically relevant DME. Intervals between visits were prescribed according to disease activity. The main outcome measure was mean aflibercept injections given through 2 years.ResultsA mean of 7.7 aflibercept injections were administered through 2 years. Fifteen (25%) patients required no retreatment and 48% (n=29) of patients received five or fewer injections through 2 years. Among patients who received at least one aflibercept retreatment during ENDURANCE, the mean number of injections through 2 years was 9.5. The mean visual acuity and central retinal thickness gains achieved during VISTA DME were maintained and stable during ENDURANCE. The most notable safety signal was progression of diabetic retinopathy. Six (10%) patients converted from non-proliferative to proliferative diabetic retinopathy (PDR), and a total of eight patients experienced PDR events occurring at a mean of 387 days following the previous aflibercept treatment.ConclusionThe need for aflibercept retreatment was substantially reduced in the fourth and fifth years of aflibercept dosing for DME following initiation of therapy in the VISTA DME trial. While vision gains achieved during the 3-year VISTA DME trial were maintained through ENDURANCE with a reduced treatment burden, clinically relevant worsening of diabetic retinopathy was observed with progression to PDR in 10% of the eyes.Trial registration numberNCT02299336

scholarly journals Comparing vision and macular thickness in neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion patients treated with intravitreal antivascular endothelial growth factor injections in clinical practice

2021 ◽  
Vol 6 (1) ◽  
pp. e000749
Author(s):  
Rajya L Gurung ◽  
Liesel M FitzGerald ◽  
Bennet J McComish ◽  
Alex W Hewitt ◽  
Nitin Verma ◽  
...  
Keyword(s):  
Growth Factor ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Age Related Macular Degeneration ◽  
Vein Occlusion ◽  
Age Related ◽  
Antivascular Endothelial Growth Factor ◽  
Endothelial Growth Factor ◽  
Median Change ◽  
Number Of Injections

ObjectiveTo compare the visual outcomes of intravitreal antivascular endothelial growth factor (anti-VEGF) injections in neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DMO) and retinal vein occlusion (RVO) in a real-world setting.Methods and analysisRetrospective analysis of data from the Tasmanian Ophthalmic Biobank database. The median change in best-corrected visual acuity (BCVA) between baseline and 12 months post initiating intravitreal anti-VEGF treatment were compared between the three diseases. Final BCVA, central macular thickness (CMT), cumulative number of injections and overall predictors of change in BCVA and CMT were also determined.ResultsAt 12 months, change in BCVA was significantly different between nAMD, DMO and RVO cohorts (p=0.032), with lower median change for DMO (2 letters, range −5 to 20) than for RVO (11 letters, range −20 to 35). Likewise, CMT change was significantly different between the three cohorts (p=0.022), with a smaller reduction in CMT in DMO (−54 µm, range −482 to 50) than RVO patients (−137 µm, range −478 to 43; p=0.033). Total number of injections received (p=0.028) and final BCVA score (p=0.024) were also significantly different between the groups. Baseline BCVA was a negative predictor (p=0.042) and baseline CMT a positive predictor (p<0.001) of outcome. After adjusting for baseline BCVA and CMT, diagnosis of nAMD or RVO was a predictor of visual improvement compared with the DMO.ConclusionsAt the end of 12 months, nAMD and RVO cohorts had the greatest improvement in BCVA, however the final BCVA for DMO was significantly better than for nAMD.

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