Dexamethasone Implant under a Proactive Treatment Regimen in a Clinical Setting: The ProDEX Study

Abstract

Purpose: To assess the effectiveness of switching intravitreal dexamethasone implants (DEX-implant) from pro re nata (PRN) treatment regimen to a proactive regimen in patients with macular edema of diverse etiologies.

Design: An observational, retrospective, uncontrolled, multicenter, national case series.

Participants: Eighty-one eyes from 68 patients treated between October 2015 and June 2023 were included.

Methods: This study included consecutive eyes treated with DEX-implant who were switched from a PRN regimen to a proactive regimen for diabetic macular edema (DME), retinal vein occlusion (RVO), noninfectious uveitis macular edema (UME; including postsurgical macular edema), and radiation maculopathy (RM).

Main outcome measures: The main outcome measures were change in the best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) at each visit.

Results: According to the etiology, DME represented 49.4% of eyes, UME 24.3%, RVO 21.0%, and RM 6.2%. The mean (standard deviation [SD]) duration of follow-up under the PRN and proactive regimens was 20.6 (13.3) and 14.2 (10.3) months, respectively. Switching from a PRN to a proactive regimen significantly improved mean (SD) BCVA by 3.7 (12.9) ETDRS letters (P = 0.01) with a mean (SD) decrease in CMT of 108.0 (151.4) μm (P < 0.001). The proportion of visits with significant anatomic recurrence (> 50 μm) also decreased from 40.1% to 6.0% after switching to a proactive regimen (P < 0.001). The number of DEX-implant injections significantly increased during the proactive treatment period (P < 0.001), but the change in the number of visits was not significantly different (P = 0.2). The proactive treatment period was not associated with a significant increase in IOP (P = 0.6).

Conclusions: Switching to a proactive regimen in patients already treated with DEX-implant seems to significantly improve BCVA and CMT while maintaining stable IOP.

Financial disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Dexamethasone implant; Injection; Macular edema; Proactive regimen.