Purpose: To compare the safety and efficacy of treatment with suprachoroidal triamcinolone acetonide (CLS-TA) plus intravitreal aflibercept vs. treatment with aflibercept alone in patients with macular edema due to retinal vein occlusion (RVO). Design: Randomized masked controlled clinical trial. Subjects: Forty-six patients with RVO. Methods: Subjects were randomized 1:1 to suprachoroidal injection of CLS-TA plus intravitreal aflibercept (combination arm) or sham suprachoroidal injection plus aflibercept (aflibercept arm), followed by aflibercept as needed at months 1, 2, and 3 in each arm. Main Outcome Measures: The primary efficacy end point was the number of protocol-required aflibercept re-treatments through month 3. Secondary outcomes included mean improvement from baseline best-corrected visual acuity (BCVA), central subfield thickness (CST), and the percentage of participants with CST ≤310 μm at each time point. Results: The number of re-treatments were reduced in the combination arm compared with that in the aflibercept arm (23 vs. 9; −61%; P = 0.013) and the percentage of participants requiring no re-treatments was increased (78% vs. 30%; P = 0.003). The mean improvement from baseline BCVA letter score in combination vs. that in the aflibercept arms was 16.1 vs. 11.4 (P = 0.20) at month 1, 20.4 vs. 11.9 (P = 0.04) at month 2, and 18.9 vs. 11.3 (P = 0.09) at month 3. The mean baseline CST in the combination arm (731.1 μm) decreased into the normal range at month 1 (284.7 μm) and remained there at months 2 and 3 (272.4 μm and 285.4 μm). The mean baseline CST (727.5 μm) in the aflibercept arm decreased to 322.8 μm at month 1 and increased at months 2 and 3 (383.4 μm and 384.6 μm). Edema resolution (CST ≤ 310 μm) occurred in 87.0%, 87.0%, and 78.3% of participants in the combination arm at months 1, 2, and 3, respectively, vs. 56.5%, 47.8%, and 47.8% of participants in the aflibercept arm. In the combination arm, 1 participant had cataract progression and 4 (2 with preexistent glaucoma) had increased intraocular pressure that was controlled with topical medication. Conclusions: Combination intravitreal aflibercept and suprachoroidal CLS-TA is well tolerated and significantly reduces the need for additional intravitreal aflibercept injections over a 3-month period in patients with RVO. Preliminary evidence suggests that combination therapy may sustain edema resolution and improve visual outcomes.
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