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Lookup NU author(s): Professor David SteelORCiD, Roxane Hillier
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© 2024 American Medical Association. All rights reserved.IMPORTANCE There 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. OBJECTIVE To determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&E) anti-VEGF injections for diabetic macular edema (DME). DESIGN, SETTING, AND PARTICIPANTS This 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. INTERVENTIONS Patients 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&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 MEASURES Rate 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. RESULTS Over 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 RELEVANCE Enrollment 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&E regimen of anti-VEGF therapy for DME.
Author(s): Maguire MJ, Laidlaw A, Hammond C, Muqit MMK, Steel D, Dinah C, Lee E, Hillier R, Almeida G, Hussain R, Gordon-Bennet P, Hughes E, Alexander P, Vaideanu-Collins D, Jackson T
Publication type: Article
Publication status: Published
Journal: JAMA Ophthalmology
Year: 2024
Pages: epub ahead of print
Online publication date: 08/08/2024
Acceptance date: 30/05/2024
ISSN (print): 2168-6165
ISSN (electronic): 2168-6173
Publisher: American Medical Association
URL: https://doi.org/10.1001/jamaophthalmol.2024.2777
DOI: 10.1001/jamaophthalmol.2024.2777
PubMed id: 39115867
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