One-Year Outcome of Aflibercept Intravitreal Injection in Vitrectomized Eyes with Diabetic Macular Edema

Abstract

Aim: To evaluate the efficacy of intravitreal Aflibercept injection (IAI) for vitrectomized eyes with diabetic macular edema (DME) at one year. Methods: This is a prospective, non-comparative, multicenter observational study including diabetic patients whose HbA1c is < 9%, with visual acuity between 20/400 to 20/40 due to DME, who have undergone vitrectomy since at least 3 months before the first aflibercept injection. Treatment protocol included 5 monthly aflibercept injection followed by a ProReNata regimen during the first year. Visual acuity, OCT findings and number of IAI were assessed at 6 months and one year. Results: Forty-six eyes were included. Indications for vitrectomy were epiretinal membrane (58.7%), intravitreal hemorrhage (26.1%), and vitreomacular traction (8.7%), retinal detachment (4.3%), and other cause (4.3%). Median duration of macular edema was 3 years. Median interval between vitrectomy and first visit was 9 months. Thirty eyes were nonnaïve and received previously thermal laser (44.3%), intravitreal injection of triamcinolone (26.7%), of ranibizumab (70%), of dexamethasone implant (36.7%), or bevacizumab (6.7%). Data was available for 35 eyes at 1 year. Visual gain was significant, +6 letters (p <0.001) and central subfield thickness (CST) decreased significantly (−108μm, p < 0.001) at 1 year. Mean number of injections was 9.3 and mean interval injection was 5.8 weeks. Conclusion:These results suggest that IAI may be beneficial in vitrectomized eyes with refractory DME which require frequent injections to obtain visual and anatomical improvement. Clinical Trial Registration: http://www.clinicaltrials.gov, registration Number NCT02874859.

Two-Year Outcome of Aflibercept Intravitreal Injection in Vitrectomized Eyes with Diabetic Macular Edema

“…6 Overall, in vitrectomized DME eyes, visual and anatomical improvement is achieved in studies with high frequency of anti-VEGF injection: 5 injections for 6 months or 10 injections for 1 year for ranibizumab 17 and 9.3 injections for aflibercept at 1 year in our previous report. 11 We also showed that visual and anatomical improvement was maintained with a decreased number of injections (5.2 injections) in year 2. 6 Resolution of fluid and improvement of VA without further treatment observed during the second year in seven eyes might be encouraging to engage the patient to the protocol treatment.…”

“…Demographic and clinical data were described in previous report. 11 Briefly, mean age was 67.5 years; most patients had type 2 disease (85%), with mean duration of diabetes of 16 years. 82.6% of patients have multiple comorbidities.…”

“… 10 We previously reported in a prospective non-comparative study that IAIs were beneficial in vitrectomized eyes with refractory DME which required frequent injections (9.3 injections with mean interval injection of 5.8 weeks for the first year) to obtain visual and anatomical improvement. 11 In a retrospective study, ranibizumab and aflibercept were found to be effective on DME in previously vitrectomized eyes, however the number of injections was found to be lower in aflibercept group. 12 …”

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“…После года терапии у пациентов после витрэктомии наблюдалась статистически значимая прибавка МКОЗ (+6 букв по шкале ETDRS, p < 0,001), которая сопровождалась существенным снижением ТЦЗС (исходная ТЦЗС (среднее): 430 мкм; изменение ТЦЗС (среднее): −108 мкм, p < 0,001). За год лечения пациентам провели в среднем 9,3 ИВИ афлиберцепта [48]. Существуют данные эффективности афлиберцепта у 14 пациентов с ДМО после витрэктомии в российской популяции в условиях реальной клинической практики.…”