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. 2023 Jun 6;12(12):3878.
doi: 10.3390/jcm12123878.

Visual and Anatomical Outcomes of a Single Intravitreal Dexamethasone in Diabetic Macular Edema: An 8 Year Real-World Study

Livia Faes  1 , Amit V Mishra  1 , Veronika Lipkova  2 , Konstantinos Balaskas  1 , Chrystie Quek  1 , Robin Hamilton  1 , Ulrike Held  3 , Dawn Sim  1   4 , Sobha Sivaprasad  1 , Dun Jack Fu  1   2
Affiliations

Visual and Anatomical Outcomes of a Single Intravitreal Dexamethasone in Diabetic Macular Edema: An 8 Year Real-World Study

Livia Faes et al. J Clin Med. .

Abstract

Importance: Diabetic macular edema (DME) is a major cause of vision loss in patients with diabetes mellitus. Intravitreal dexamethasone is a treatment option for patients unsuitable for or non-responsive to anti-angiogenic agents.

Objective: To quantify visual and anatomical outcomes from an initial intravitreal dexamethasone injection over the expected 6-month period of dexamethasone release by the implant. Design and enrolment: This is a retrospective cohort study using electronic medical records of patients reviewed between 1 January 2012 and 1 April 2022.

Setting: A tertiary eye-care center in London, United Kingdom; Moorfields Eye Hospital National Healthcare System Foundation Trust.

Participants: The cohort comprised 418 adult patients with DME who received an initial treatment of 700 µg intravitreal dexamethasone in the study period. Of these, 240 patients met the inclusion criteria of ≥2 hospital visits following initial injection (≥1 beyond 6 months) and no previous ocular corticosteroid treatment or missing assessment at baseline.

Exposure(s): Intravitreal dexamethasone implant (700 µg).

Main outcome(s) and measure(s): Probability of a positive visual outcome, defined as ≥5 or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS)-letter gain after treatment when compared to baseline (Kaplan-Meier models).

Results: From the initial intravitreal dexamethasone injection alone, we observed a >75% chance of gaining ≥5 ETDRS letters and >50% chance of gaining ≥10 ETDRS letters within 6 months. There was less than a 50% chance of sustaining either positive visual outcome beyond 4 months.

Conclusions and relevance: Most patients can be expected to have a positive visual outcome following an initial injection of dexamethasone implants that subsides within 4 months. Real-world re-treatment was observed to be delayed until after visual benefits were lost in half of the cohort. Further research will be needed to study the effects of delays in re-treatment.

Keywords: diabetic macular edema; survival analysis; visual outcome.

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Conflict of interest statement

D.J.F. reports other relevant financial activities outside the submitted work with Abbvie, Allergan, Apellis, and DeepMind. A.V.M. reports no conflict of interest. V.L. reports no conflict of interest. L.F. reports other relevant financial activities outside the submitted work with Bayer and Allergan. D.S. is a lead medical director at Genentech and has received funding/fees from Bayer, Novartis, Allergan, and Roche. S.S. has received funding/fees from Bayer, Novartis, Allergan, Roche, Boehringer Ingelheim, Optos, Oxurion, Oculis, Biogen, Apellis, and Heidelberg Engineering. K.B. has received speaker fees from Novartis, Bayer, Alimera, Allergan, and Heidelberg, has done consulting for Novartis and Roche, and has received research support from Apellis, Novartis, and Bayer. U.H. reports receiving financial compensation for giving a talk outside the submitted work from CSL Behring. R.H. has received funding/fees from Bayer, Novartis, Allergan and Roche.

Figures

Figure 1
Figure 1
Monthly sampling of visual and anatomical outcomes up to 6 months following initial intravitreal dexamethasone. (a) Mean visual acuity (Early Treatment Diabetic Retinopathy Study (ETDRS) letters; black and central subfoveal thickness (μm; red) following initial intravitreal dexamethasone. (b) Mean change in VA and central subfoveal thickness from baseline. Error bars signify 95% confidence intervals.
Figure 1
Figure 1
Monthly sampling of visual and anatomical outcomes up to 6 months following initial intravitreal dexamethasone. (a) Mean visual acuity (Early Treatment Diabetic Retinopathy Study (ETDRS) letters; black and central subfoveal thickness (μm; red) following initial intravitreal dexamethasone. (b) Mean change in VA and central subfoveal thickness from baseline. Error bars signify 95% confidence intervals.
Figure 2
Figure 2
Data capture at monthly time points. Distinct clinical visits where visual acuity was measured are plotted (blue dots). X-axis depicts time following initial intravitreal dexamethasone and was restricted to the first 2 years. Blue-shaded area represents the 4-month time point—120 days post initial injection with a 10-day margin. Distinct patients represented along the y-axis and arranged so that patients with a clinical visit within the 4-month time point are at the top. Here it is demonstrated that an absent value does not suggest absence of follow-up. Of the 134 persons without a visual-acuity measurement at the 4-month time point, 100% (135/135) had a measurement following the 4-month period.
Figure 3
Figure 3
Probability of a positive visual outcome from an initial intravitreal dexamethasone injection. Kaplan–Meier modelling was carried out to estimate the probability of gaining (a) 5 or more ETDRS letters (Snellen equivalent 1 line) and (b) 10 or more ETDRS letters. Grey fill represents 95% confidence intervals. Tick marks indicate censored data, with remaining numbers at risk shown in the legend below.
See this image and copyright information in PMC

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