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Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
Sponsor: SANGMYUNG innovation
Summary
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.
Official title: A Multicenter, Randomized, Double-blind, Parallel Design, Active-controlled Phase 3 Study to Determine Efficacy and Safety Following Administration of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2026-01-29
Completion Date
2028-01
Last Updated
2026-07-16
Healthy Volunteers
No
Interventions
Reference Drug
1. Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 \~ 3). 2. Single administration of the reference drug at Day 0.
SMO1
1\. Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 \~ 3). 2. Single administration of SMO1 at Day 0.
Locations (1)
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea