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.

ClinicalTrials.gov Identifier

NCT01976650. Date of registration: November 6, 2013.

Keywords:

• retinal vein occlusion
• dexamethasone
• intravitreal
• implant
• post-marketing
• real world

Korea Ozurdex Post Marketing Surveillance Study Group

Jeeyun Ahn (SMG-SNU Boramae Medical Center, Seoul, KR); Jeong-Hun Bae (Kangbuk Samsung Hospital, Seoul, KR); Woohyok Chang (Chang’s Retina Center, Daegu, KR); Ju Byung Chae (Chungbuk National University Hospital, Cheongju, KR); Young-Wook Cho (Daegu Fatima Hospital, Daegu, KR); Kyung-Seek Choi (Soonchunhyang University Seoul Hospital, Seoul, KR); In Young Chung (Gyeongsang National University Hospital, Jinju, KR); Jang-Won Heo (Seoul National University Hospital, Seoul, KR); Daniel Duck-Jin Hwang (HanGil Eye Hospital, Incheon, KR); Donghyun Jee (St. Vincent Hospital Suwon, KR); Yeong-Seok Ji (Chonnam National University Hospital, Gwangju, KR); Jae-Uk Jeong (Keimyung University Dongsan Medical Center, Daegu, KR); Soo-Geun Joe (Asan Medical Center, Seoul, KR); Se Woong Kang (Samsung Medical Center, Seoul, KR); Chul-Gu Kim (Kim’s Eye Hospital, Seoul, KR); Han Gyu Kim (Pureun Eye Clinic Center, Jeonju, KR); June-Gone Kim (Asan Medical Center, Seoul, KR); Kwang-Su Kim (Keimyung University Dongsan Medical Center, Daegu, KR); Moo Sang Kim (Kangwon National University Hospital, Gangwon-do, KR); Sang-Jin Kim (Samsung Medical Center, Seoul, KR); Yeong-Deok Kim (Bora Eye Hospital, Gwangju, KR); Yu Cheol Kim (Keimyung University Dongsan Medical Center, Daegu, KR); Yun-Taek Kim (Ewha Women’s University Mokdong Hospital, Seoul, KR); Yun-Young Kim (Daegu Catholic University Medical Center); Hyoung Jun Koh (Yonsei University Severance Hospital, Seoul, KR); Oh Woong Kwon (Nune Eye Hospital, Seoul, KR); Yoon-Hyung Kwon (Dong-A University Medical Center, Busan, KR); Byung Ro Lee (Hanyang University Seoul Hospital, Seoul, KR); Dae-Young Lee (Gachon University Gil Hospital, Incheon, KR); Ji-Eun Lee (Pusan National University Hospital, Busan, KR); Jong-Hyun Lee (Inje University Ilsan Paik Hospital Medical Center, Goyang, KR); Joo-Eun Lee (Inje University Haeundae Paik Hospital, Busan, KR); Jung-Ho Lee (Cheil Eye Hospital, Daegu, KR); Sung-Jin Lee (Soonchunhyang University Seoul Hospital, Seoul, KR); Young Hoon Lee (Konyang University Hospital, Daejeon, KR); Sun Taek Lim (Bora Eye Hospital, Gwang-ju, KR); Jong-Hyun Oh (Dongguk University Ilsan Hospital, Goyang, KR); Dong Ho Park (Kyungpook National University Hospital, Daegu, KR); Sung Pyo Park (Gangdong Sacred Heart Hospital, Seoul, KR); Young-Hoon Park (The Catholic University of Korea Seoul St. Mary’s Hospital, Seoul, KR); Min Sagong (Yeungnam University Medical Center, Daegu, KR); Jae-Ho Shin (Kyung Hee University Hospital at Gangdong, Seoul, KR); Ji-Hun Song (Ajou University Hospital, Suwon, KR); Won-Kyung Song (CHA Bundang Medical Center of CHA University, Seongnam, KR); Se-Joon Woo (Seoul National University Bundang Hospital, Seongnam, KR); Hyeong-Gon Yu (Seoul National University Hospital, Seoul, KR); Il-Han Yun (Inje University Busan Paik Hospital, Busan, KR).

Data Sharing Statement

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Acknowledgments

Medical writing and editorial assistance were provided to the authors by Michelle Kwon, PhD, of Evidence Scientific Solutions, Inc (Philadelphia, PA) and funded by AbbVie Inc.

Author Contributions

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. The sponsor participated in the design of the study, data management, analysis and interpretation, and preparation, review, and approval of the manuscript. All authors met the ICMJE authorship criteria. No honoraria or payments were made for authorship.

Disclosure

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.

Additional information

Funding

This study was sponsored by Allergan (prior to its acquisition by AbbVie).