Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea

Abstract

Purpose: To supplement established efficacy and safety data, this analysis evaluated the real-world use of dexamethasone (DEX) intravitreal implant 700 µg for retinal vein occlusion (RVO)-related macular edema in an Asian population and baseline factors potentially associated with DEX implant efficacy.

Patients and methods: A prospective, observational, post-marketing surveillance study was conducted at 38 sites in South Korea in patients consecutively presenting with macular edema following branch or central RVO (BRVO, CRVO), and administered a first DEX implant. Follow-up visits and subsequent DEX or other therapies conformed with local practice. Outcome measures included best-corrected visual acuity (BCVA), change in BCVA from baseline, responder rates, and adverse events. Associations between baseline characteristics and BCVA gains were evaluated. Month-1, -2, -4, and -6 visit analysis windows were established.

Results: In all, 700 patients (79.1% BRVO, 20.9% CRVO) received 1.12 DEX implants (mean) and were followed for 101.5 days (standard deviation, 51.7); 90% received a single implant. Among patients with analyzable data, mean BCVA improved from baseline with peak changes in Month 2 of -0.193 and -0.212 LogMAR, (P < 0.0001) and remained significant in the BRVO subgroup at the Month 4 and 6 windows (P < 0.0001 and P = 0.0039, respectively). Treatment-naïve patients experienced greater BCVA increases. The proportion of patients with stable/improved BCVA tended to decrease after Month 2 through Month 6 and the decline was greater in the CRVO subgroup. At the Month-2 window, ≥1-, 2- and 3-line increases were positively associated with younger age, worse baseline BCVA, and treatment naivety. The most common adverse event was increased intraocular pressure.

Conclusion: In the real-world clinical setting in South Korea, DEX implant improved visual acuity and had a favorable safety profile similar to that reported in randomized controlled trials and observational European and North American studies. These data further support the value of DEX implant as a treatment option for RVO.

Clinicaltrialsgov identifier: NCT01976650. Date of registration: November 6, 2013.

Keywords: dexamethasone; implant; intravitreal; post-marketing; real world; retinal vein occlusion.

Conflict of interest statement

Min Seok Kim declares no relevant financial or non-financial conflicts of interest. Jasmine Choi and Hyeong Du Lee are employee of AbbVie Inc. Se Joon Woo has received research support from Samsung Bioepis, Novelty Nobility, Novartis, Alteogen and Curacle; consultant fees from Samsung Bioepis and Panolos Bioscience; lecture fees from Novartis, Bayer, Allergan, AbbVie, Taejoon, Alcon, Philophos, and SCAI Therapeutics; and owns stock in Retimark and Panolos Bioscience. Se Joon Woo has also served on the scientific advisory boards of Novelty Nobility and Novartis. The authors report no other conflicts of interest in this work.

© 2021 Kim et al.

Figures

Figure 1

Subject flow diagram for post-hoc analysis of post-marketing surveillance (PMS) study of dexamethasone intravitreal implant use in patients with branch retinal vein or central retinal vein occlusion.

Figure 2

(A) Mean best-corrected visual acuity and (B) mean change in best-corrected visual acuity from baseline in patients with BRVO or CRVO.

Figure 3

Mean change in best-corrected visual acuity from baseline in (A) BRVO patients and (B) CRVO patients by treatment naivety.

Figure 4

Improvements in best-corrected visual acuity of (A) ≥0 line, (B) ≥1 line, (C) ≥2 line, and (D) ≥3 line from baseline within each analysis window.

Figure 5

Distribution of best-corrected visual acuity of (A) ≥1 line, (B) ≥2 line, or (C) ≥3 line decreases from baseline within each analysis window.