Condition: Retinal Vein Occlusion With Macular Edema · Sponsor: SANGMYUNG innovation
This is a multicenter, randomized, double-masked, parallel-group, active-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of SMO1 (Dexamethasone 700μg intravitreal implant) compared with the reference drug (Dexamethasone 700μg intravitreal implant) in patients with retinal vein occlusion (RVO)-associated macular edema. Participants are randomized in a 1:1 ratio to receive either the reference drug or the investigational product, SMO1, following screening and baseline assesments. Randomization is centrally managed and stratified by RVO subtype (branch or central). Patients are followed for 6 months with scheduled visits to assess efficacy and safety endpoints. A total of 312 participants (156 per treatment arm) will be enrolled.
This description comes directly from the study's public registry record.
Nahyun Kang, Ph.D · +82 2-3489-6298 · nahyun.kang@sminnovation.com
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| Kyung Hee University Hospital at Gangdong | Seoul, Gangdong-gu, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07708142