Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study)

Glassman, Adam R.; Wells, John A.; Josic, Kristin; Maguire, Maureen G.; Antoszyk, Andrew N.; Baker, Carl W.; Beaulieu, Wesley T.; Elman, Michael J.; Jampol, Lee M.; Sun, Jennifer K.

doi:10.1016/j.ophtha.2020.03.021

Cited by 122 publications

(123 citation statements)

References 13 publications

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“…This protocol compared the efficacy and safety of aflibercept, bevacizumab and ranibizumab for the treatment of CI‐DME in eyes with VA of 20/32 to 20/320 66,67,78 . The treatment algorithm was fairly complex, a blend of treat and extend vs monthly injections.…”

Section: Landmark Dr Studiesmentioning

confidence: 99%

“…Anti‐VEGF monotherapy currently is the first line treatment for CI‐DME. When treating eyes with a VA 20/40 or worse, aflibercept, bevacizumab and ranibizumab have comparable efficacies at 2 years 66,67 . Patients with excellent vision (20/25 or better) with CI‐DME may be monitored without injection; based on http://drcr.net Protocol V, these patients should be monitored every 2 to 4 months with aflibercept given if VA decreases 79 …”

Section: Current Recommendations For Diabetic Eye Disease Managementmentioning

confidence: 99%

“…This protocol compared the efficacy and safety of aflibercept, bevacizumab and ranibizumab for the treatment of CI-DME in eyes with VA of 20/32 to 20/320. 66,67,78 The treatment algorithm was fairly complex, a blend of treat and extend vs monthly injections. Aflibercept had better visual outcomes compared to ranibizumab and bevacizumab at 1 year, but aflibercept was only better than bevacizumab at 2 years.…”

Section: Protocol S and Clarity Studymentioning

confidence: 99%

“…When treating eyes with a VA 20/40 or worse, aflibercept, bevacizumab and ranibizumab have comparable efficacies at 2 years. 66,67 Patients with excellent vision (20/25 or better) with CI-DME may be monitored without injection; based on DRCR.net Protocol V, these patients should be monitored every 2 to 4 months with aflibercept given if VA decreases. 79 Many studies have demonstrated that focal laser alone is less effective than anti-VEGF injections for CI-DME.…”

Section: Clinically Significant Diabetic Macular Oedemamentioning

confidence: 99%

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Diabetic eye disease: A review of screening and management recommendations

Gale

Scruggs

Flaxel

2021

Clinical Exper Ophthalmology

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The prevalence of diabetes is rapidly increasing, and it is now the leading cause of blindness worldwide. Although early detection of diabetic retinopathy is key to preventing vision loss, many patients do not receive appropriate examinations. Using a multidisciplinary approach, primary care physicians and eye care providers should follow evidence‐based recommendations for screening and monitoring diabetic patients while working to improve patients' glycaemic index, blood pressure, and metabolic risk factors. Anti‐vascular endothelial growth factor intravitreal injections in combination with panretinal photocoagulation and focal laser treatment remain the cornerstones of modern therapy. The many landmark studies for diabetic eye disease management should guide counselling and decision making for treating diabetic macular oedema, proliferative retinopathy and other diabetes‐related eye diseases.

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Section: Landmark Dr Studiesmentioning

confidence: 99%

Section: Current Recommendations For Diabetic Eye Disease Managementmentioning

confidence: 99%

Section: Protocol S and Clarity Studymentioning

confidence: 99%

Section: Clinically Significant Diabetic Macular Oedemamentioning

confidence: 99%

See 2 more Smart Citations

Diabetic eye disease: A review of screening and management recommendations

Gale

Scruggs

Flaxel

2021

Clinical Exper Ophthalmology

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“…Most RCTs included a 2–5-year protocol 5 , 11 , and anti-VEGF therapy in DME usually lasts for at least several years. The financial costs of multiple anti-VEGF injections are sometimes not affordable for patients with DME, especially, after the second or third year, which can lead to deterioration in vision 13 . Consequently, various modified treatment regimens have been evaluated to reduce the number of injections and follow-up visits while maintaining the therapeutic effects.…”

Section: Introductionmentioning

confidence: 99%

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

Hirano

Toriyama

Takamura

et al. 2021

Sci Rep

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This 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.

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Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema

Maguire,

Laidlaw,

Hammond

et al. 2024

JAMA Ophthalmol

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ImportanceThere are reported benefits from vitrectomy for diabetic macular edema (DME); however, data precede anti–vascular endothelial growth therapy (VEGF) therapy, supporting a need to assess the current role of vitrectomy.ObjectiveTo determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&amp;E) anti-VEGF injections for diabetic macular edema (DME).Design, Setting, and ParticipantsThis was a single-masked, multicenter randomized clinical trial at 21 sites in the United Kingdom from June 2018 to January 2021, evaluating single eyes of treatment-naive patients with symptomatic vision loss from DME for less than 1 year. Inclusion criteria were best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score greater than 35 (approximate Snellen equivalent, 20/200 or better) and central subfield thickness (CST) greater than 350 μm after 3 monthly intravitreal injections of ranibizumab or aflibercept. Data analysis was performed in July 2023.InterventionsPatients were randomized 1:1 into vitrectomy plus standard care or standard care alone and further stratified into groups with vs without vitreomacular interface abnormality. Both groups received a T&amp;E anti-VEGF injection regimen with aflibercept, 2 mg, or ranibizumab, 0.5 mg. The vitrectomy group additionally underwent pars plana vitrectomy with epiretinal membrane or ILM peel within 1 month of randomization.Main Outcomes and MeasuresRate of recruitment and distance BCVA. Secondary outcome measures were CST, change in BCVA and CST, number of injections, rate of completed follow-up, and withdrawal rate.ResultsOver 32 months, 47 of a planned 100 patients were enrolled; 42 (89%; mean [SD] age, 63 [11] years; 26 [62%] male) completed 12-month follow-up visits. Baseline characteristics appeared comparable between the control (n = 23; mean [SD] age, 66 [10] years) and vitrectomy (n = 24; mean [SD] age, 62 [12] years) groups. No difference in 12-month BCVA was noted between groups, with a 12-month median (IQR) BCVA letter score of 73 (65-77) letters (Snellen equivalent, 20/40) in the control group vs 77 (67-81) letters (Snellen equivalent, 20/32) in the vitrectomy group (difference, 4 letters; 95% CI, −8 to 2; P = .24). There was no difference in BCVA change from baseline (median [IQR], −1 [−3 to 2] letters for the control group vs −2 [−8 to 2] letters for the vitrectomy group; difference, 1 letter; 95% CI, −5 to 7; P = .85). No difference was found in CST changes (median [IQR], −94 [−122 to 9] μm for the control group vs −32 [−48 to 25] μm for the vitrectomy group; difference, 62 μm; 95% CI, −110 to 11; P = .11).Conclusions and RelevanceEnrollment goals could not be attained. However, with 47 participants, evidence did not support a clinical benefit of vitrectomy plus ILM peeling as an adjunct to a T&amp;E regimen of anti-VEGF therapy for DME.Trial Registrationisrctn.org Identifier: ISRCTN59902040

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Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study)

Cited by 122 publications

References 13 publications

Diabetic eye disease: A review of screening and management recommendations

Diabetic eye disease: A review of screening and management recommendations

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

Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema

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