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

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 Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results

2020 ◽  
pp. bjophthalmol-2020-316176
Author(s):  
John F. Payne ◽  
Charles C. Wykoff ◽  
W. Lloyd Clark ◽  
Beau B. Bruce ◽  
David S. Boyer ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Laser Photocoagulation ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Randomised Clinical Trial ◽  
Long Term Effects ◽  
Treat And Extend ◽  
The Third ◽  
Navigated Laser

Background/aimsTo evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME).MethodsThis is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 µm, and all eyes were eligible to receive focal laser.Results109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 µm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year.ConclusionThe improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections.Trial registration numberFDA IND 119146, NCT01934556.

scholarly journals The South African macular oedema in diabetics study (the same study): a prospective randomized non-inferiority trial

2020 ◽  
Vol 7 (4) ◽  
pp. 255
Author(s):  
Naseer Ally ◽  
Sarah Ismail ◽  
Bongi P. Sithole ◽  
Mpho Tsimanyane ◽  
Ismail Mayet ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Cost Effective ◽  
Standard Of Care ◽  
Current Standard ◽  
Treat And Extend ◽  
Anti Vegf ◽  
Trial Testing ◽  
Pro Re Nata

<p class="abstract"><strong>Background:</strong> Diabetic retinopathy is the most common cause of visual loss affecting the economically productive age group globally. Diabetic macular oedema (DMO) results from leakage of fluid into the retinal interstitial space. Anti-vascular endothelial growth factor (anti-VEGF) drugs are the first line treatment for DMO. Since monthly injections are required, this treatment regimen can prove very costly. Of the anti-VEGF drugs, bevacizumab is the most cost-effective. The pro re nata (PRN) method is the current standard of care. However, the treat and extend (T and E) regimen can potentially decrease the patient burden on hospitals. Thus far, no randomised clinical trials have been performed using Bevacizumab in a treat and extend versus pro re nata regimen.</p><p class="abstract"><strong>Methods:</strong> A prospective randomised non-inferiority clinical trial testing bevacizumab (1.25 mg) in a treat and extend method versus the pro re nata method is being conducted. Patients will be randomised using a simple computer-based randomised algorithm. The primary outcome is non-inferiority within a five-letter margin for the T and E regimen versus the PRN regimen.</p><p class="abstract"><strong>Conclusions: </strong>This study aims to inform a key area in the literature on the treatment of DMO, i.e. whether a T and E regimen is non-inferior to a PRN regimen in the treatment of DMO with bevacizumab, which is the only anti VEGF available in resource poor settings. It is motivated by the cost involved in the treatment of DMO as well as the treatment burden on both the patient and the health institution at which the patient is receiving treatment.</p><p class="abstract"><strong>Trial registration:</strong> The trial has been registered on the Pan-African clinical trials registry (PACTR202001624880-753).</p>

scholarly journals Real-World Evidence for Treat-and-Extend Regimen of Ranibizumab Therapy for Macular Oedema Secondary to Branch Retinal Vein Occlusion

2022 ◽  
Vol 15 (1) ◽  
pp. 59
Author(s):  
Carmen Antía Rodríguez-Fernández ◽  
Ana Campo-Gesto ◽  
Aida López-López ◽  
Mónica Gayoso-Rey
Keyword(s):  
Retinal Vein Occlusion ◽  
Macular Oedema ◽  
Branch Retinal Vein Occlusion ◽  
Intravitreal Ranibizumab ◽  
Treat And Extend ◽  
Vein Occlusion ◽  
Real World Evidence ◽  
First Choice ◽  
Treat And Extend Regimen

The aim of this study was to evaluate the efficacy of a treat-and-extend (T&E) regimen of ranibizumab as the first-choice treatment in macular oedema (MO) secondary to branch retinal vein occlusion (BRVO). We conducted a retrospective study of 20 patients who developed MO due to BRVO treated with intravitreal ranibizumab in a T&E regimen between 2016 and 2017 with a minimum follow-up of two years. Patients were classified as complete responders if treated with ranibizumab alone or incomplete responders if salvage treatment with other medications or laser was needed. Data on best corrected visual acuity (BCVA) and central macular thickness (CMT) every 6 months were recorded. The mean BCVA (logMAR) improved from 0.60 ± 0.36 to 0.29 ± 0.44 and the CMT decreased from 559.85 ± 198.61 to 305.85 ± 11.78 μm. We found statistically significant differences between complete and incomplete responders on the average number of injections during the second year (2.46 ± 2.18 compared to 5.43 ± 1.27; p = 0.007) and change of the BCVA and CMT between both groups (p < 0.001) at 6, 12, 18 and 24 months. T&E seems to be effective in MO secondary to BRVO, improving visual function and decreasing CMT, with less need for injections.

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 Predictors for 2-year functional and morphological outcomes of a treat and extend regimen with ranibizumab in patients with diabetic macular edema

2021 ◽  
Author(s):  
Helena Giannakaki-Zimmermann ◽  
Alexandra Behrndt ◽  
Laura Hoffmann ◽  
Maria-Magdalena Guichard ◽  
Cengiz Tuerksever ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Loading Dose ◽  
Treatment Frequency ◽  
Treat And Extend ◽  
Free Treatment ◽  
Younger Age ◽  
One Year ◽  
Treat And Extend Regimen

Abstract Purpose: To investigate longer-term functional and morphological outcomes and their predictors in diabetic macular edema (DME) following a treat and extend regimen (TER) without loading dose under ranibizumab. Methods: Patient data were reviewed and analyzed retrospectively over a period of 24 months after initiation of TER. Best-corrected visual acuity (BCVA), treatment frequency as well as quantitative and qualitative Spectral-domain Optical Coherence Tomography parameters were assessed. Results: 118 eyes of 87 patients were included. A mean of 9.742.13 injections in the first and 7.632.29 in the second year were applied. There were significant gains of BCVA and reductions in central retinal thickness from baseline to month 12 and 24 (all p<0.001). Percentage of eyes with an intact inner-/outer segment (IS/OS) junction increased from 15.3% at baseline to 42.1% at month 24 (p<0.001). An intact IS/OS junction at baseline increased the probability of having a dry retina after 12 months by 79.3% (p=0.017) and after 24 months by 88.1% (p=0.040). Less IS/OS disruption at baseline predicted longer maximum recurrence-free treatment intervals at 2 years (r=-0.345, p<0.001) and better BCVA at one year (r=-0.347, p<0.001). Baseline bigger intraretinal cysts were associated with more IS/OS disruption at 24 months (r=0.305, p=0.007). Younger age and lower BCVA at baseline were predictive for a higher BCVA gain at 24 months (p=0.046, p<0.001). Conclusion: Ranibizumab applied in a TER without loading dose in DME significantly improves visual acuity and retinal anatomical structure throughout two years. The evaluated predictors might help to guide routine clinical treatment in DME.

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