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Randomized Controlled Trial
. 2024 Sep 1;142(9):837-844.
doi: 10.1001/jamaophthalmol.2024.2777.

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

Matthew J Maguire  1 , Alistair Laidlaw  1 , Christopher Hammond  1 , Mahiul Muhammed Khan Muqit  2 , David Steel  3 , Christiana Dinah  4 , Edward Lee  5 , Roxane Hillier  6 , Goncalo Almeida  7 , Rumana Hussain  8 , Patel Gordon-Bennet  9 , Edward Hughes  10 , Philip Alexander  11 , Daniela Vaideanu-Collins  12 , Tim Jackson  13
Affiliations
Randomized Controlled Trial

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

Matthew J Maguire et al. JAMA Ophthalmol. .

Abstract

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.

Trial registration: isrctn.org Identifier: ISRCTN59902040.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Maguire reported receiving funding from Fight for Sight UK during the conduct of the study. Dr Laidlaw reported being an owner and developer of COMPlog Clinical Vision Measurement Systems Ltd outside the submitted work. Dr Steel reported receiving grants from Alcon, Dutch Ophthalmic Research Centre, BVI, Roche, Boehringer Ingelheim, Gyroscope, and Bayer and personal fees from Alcon, Alimera, Eyepoint, Dutch Ophthalmic Research Centre, BVI, Gyroscope, and Complement Therapeutics outside the submitted work. Dr Dinah reported receiving personal fees from Bayer and grants from Roche outside the submitted work. Dr Hillier reported receiving personal fees from Roche outside the submitted work. Dr Jackson reported being a consultant or advisor to 2CTech, Alcon, Dutch Ophthalmic Research Centre, iLumen, Opthea, Outlook Therapeutics, Oxurion, and Regeneron and receiving conference support from Roche. The National Health Service receives site payments for patients recruited to commercial clinical trials, including trials of diabetic eye disease. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram to Outline Recruitment Process
CST indicates central subfield thickness; DME, diabetic macular edema; VEGF, vascular endothelial growth factor.
Figure 2.
Figure 2.. Recruitment Numbers for the Vitrectomy in Diabetic Macular Oedema (VIDEO) Trial by Month From June 2018 Until January 2021
The inclusion of aflibercept, additional sites, and the first UK national lockdown due to COVID-19 are highlighted. NOSA indicates notification of substantial amendment.
See this image and copyright information in PMC

References

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