Vitrectomy Added to Anti-VEGF Therapy Lacks Benefit for DME

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Evidence from the randomized Vitrectomy in Diabetic Macular Edeema (VIDEO) clinical trial described no benefit of vitrectomy with internal limiting membrane (ILM) peeling added to a treat-and-extend anti-vascular endothelial growth factor (VEGF) regimen on visual or anatomic outcomes in diabetic macular edema (DME).¹

However, the trial did not attain the expected enrollment goals, with only 47 of 100 patients enrolled over 32 months. Despite missing more than half of patients, the study reported no differences in best-corrected visual acuity (BCVA), central subfield thickness (CST), or change in parameters from baseline to 12 months between study groups.

“Our results demonstrate that a full trial comparing standard care vs standard care plus pars plana vitrectomy (PPV) may be feasible, although enrollment goals were not attained in the study,” wrote the investigative team, led by Matthew J. Maguire, MBBS, department of academic ophthalmology, Guy’s and St Thomas’ NHS Foundation Trust. “However, there was no evidence found to suggest a beneficial clinical effect of vitrectomy and ILM peeling as an adjunct to T&E anti-VEGF therapy alone.”

Published literature has reported the potential benefit of vitrectomy for DME outcomes, but interpretation is limited due to differences in inclusion criteria, outcome measures, and follow-up periods.² Although data show vitrectomy has more effect than laser in reducing DME and CST, these findings precede anti-VEGF therapy and describe the need for a current assessment of vitrectomy’s role in DME.³

In this study, Maguire and colleagues aimed to describe the rate of recruitment and efficacy outcomes of vitrectomy plus ILM peeling adjunctive to T&E anti-VEGF injections for DME. VIDEO was a single-masked RCT performed at 21 sites in the United Kingdom from June 2018 to January 2021.

The study assessed single eyes of treatment-naive patients with DME experiencing symptomatic vision loss for less than 1 year. Patients had Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores ≥35 (Snellen equivalent, 20/200 or better) and CST ≥350 µm after 3 months of intravitreal injections with ranibizumab or aflibercept.

Investigators randomized patients 1:1 to vitrectomy in addition to standard of care, or standard care alone – the population was further separated into cohorts with or without vitreomacular interface abnormality. Each cohort received a T&E anti-VEGF regimen with aflibercept 2 mg or ranibizumab 0.5 mg.

Those in the vitrectomy cohort also underwent PPV with epiretinal membrane or ILM peel within 1 month of randomization. Primary outcomes were the rates of recruitment and distance BCVA, with secondary outcomes including CST, change in BCVA and CST, number of injections, rates of completed follow-up, and withdrawal rate.

Across 32 months, 47 of the planned 100 patients were enrolled in VIDEO. Of this population, 42 (89%; mean age, 63 years) completed 12-month follow-up visits. Baseline characteristics were similar between the control (n = 23; mean age, 66 years) and vitrectomy (n = 24; mean age, 62 years) cohorts.

Upon analysis, Maguire and colleagues found no difference in 12-month BCVA between the control (BCVA, 73 letters [20/40]) and vitrectomy (77 letters [20/32]) cohorts (difference, 4 letters [95% CI, –8 to 2]; P = .24).

In particular, there was no difference in change from baseline for the control (median, –1 letter) and vitrectomy (median, –2 letters) cohorts (difference, 1 letter [95% CI, –5 to 7]; P = .85). Further, there were no differences observed in CST changes between the control (median, –94 µm) and vitrectomy (median, –32 µm) cohorts (difference, 62 µm [95% CI, –110 to 11; P = .11).

“Despite the intervening COVID-19 pandemic, which canceled recruitment for more than a year, such a trial might be feasible regarding the willingness of centers and patients to participate,” Maguire and colleagues wrote. “We estimate that the COVID-19 pandemic halved the potential recruitment from participating centers within our available resources.”

References

1. _{Maguire MJ, Laidlaw A, Hammond C, et al. Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema: The Vitrectomy in Diabetic Macular Oedema (VIDEO) Randomized Clinical Trial. JAMA Ophthalmol. Published online August 08, 2024. doi:10.1001/jamaophthalmol.2024.2777}
2. _{Figueroa MS, Contreras I, Noval S. Surgical and anatomical outcomes of pars plana vitrectomy for diffuse nontractional diabetic macular edema. Retina. 2008;28(3):420-426. doi:10.1097/IAE.0b013e318159e7d2}
3. _{Michalewska Z, Stewart MW, Landers MB 3rd, Bednarski M, Adelman RA, Nawrocki J. Vitrectomy in the management of diabetic macular edema in treatment-naïve patients. Can J Ophthalmol. 2018;53(4):402-407. doi:10.1016/j.jcjo.2017.10.011}