Work

Time-in-Range Analysis of Responses after Intravitreal Dexamethasone Therapy in Eyes with Diabetic Macular Edema

Year: 2025

Type: article

Abstract: Purpose: Time in range (TIR) is a novel end point that assesses the time during which an outcome remains within a predetermined range. Because the range includes normal parameters, it is indicative of clinically meaningful benefit. The MEAD trial comprised two 3-year randomized, multicenter, sham-controlled, phase III clinical studies that evaluated the efficacy and safety of dexamethasone intravitreal implant (DEX-I) in patients with diabetic macular edema. Dexamethasone intravitreal implant significantly improved best-corrected visual acuity (BCVA) and central retinal thickness (CRT) compared with sham treatment. We present a post hoc analysis of the MEAD trial to investigate TIR benefit across various thresholds of BCVA and CRT with DEX-I versus sham. Design: Post hoc analysis of results from the randomized, multicenter, sham-controlled, phase III MEAD trial (NCT00168337 and NCT00168389). Participants: Adults with type 1 or 2 diabetes mellitus and fovea-involved macular edema associated with diabetic retinopathy. Intervention: Intravitreal injection of DEX-I 0.7 mg or sham procedure. Main Outcome Measures: Time in range during year 1 was evaluated using BCVA thresholds of ≥69, ≥51, ≥59, and ≥64 letters, and CRT thresholds of <300, <353, <446, and <551 μm (the latter cutoffs being quartile [Q] 1, Q2, and Q3 of pooled baseline BCVA and CRT, respectively). Results: 0.001). Conclusions: Patients receiving intravitreal DEX-I 0.7 mg had a longer time with BCVA above the driving threshold and below the normal limit of CRT during year 1 of the MEAD trial versus those who received sham. These results suggest that patients treated with dexamethasone experience a longer time with clinically meaningful outcomes than with sham, such as being able to drive or regaining normal structural retinal features. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Source: Ophthalmology Science

DOI: 10.1016/j.xops.2025.100833

Authors: Igor Kozak, Diana V. Do, Hongxin Lai, Miller J. Ogidigben, Francisco J. López

Institutions: University of Arizona, Stanford University

Language: English

Topic: Retinal Diseases and Treatments

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,500