SMO1 vs reference dexamethasone implant for retinal vein occlusion with macular edema
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
Run by SANGMYUNG innovation · NCT07708142 · Data updated 2026-11-12
This trial tests SMO1, a dexamethasone implant, to see if it works as well as the standard implant in people with vein blockage-related macular swelling in the eye.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 312 (estimated) |
| Sponsor | SANGMYUNG innovation Industry-sponsored |
| Locations | 1 site (Seoul, Gangdong-gu) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | July 2027 |
| Study ends | January 2028 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07708142 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 19 years and older with BRVO or CRVO–related macular edema, sufficient visual acuity, and a central retinal thickness of 300 μm or greater at screening.
✕Probably not a fit
Patients with macular edema unlikely to improve or with uncontrolled glaucoma may not benefit from SMO1 treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, double-masked Phase 3 trial comparing SMO1 (Dexamethasone 700 μg implant) with the reference dexamethasone implant in patients with macular edema due to retinal vein occlusion. Participants are assigned 1:1 and stratified by BRVO or CRVO, then followed for 6 months to monitor efficacy and safety. The study plans to enroll 312 participants, with 156 in each arm, to assess outcomes using standard ophthalmic endpoints and imaging. Central randomization and masking help ensure unbiased comparison of the two treatments. The trial is led by Sangmyung Innovation with collaboration at Kyung Hee University Hospital in Seoul.
Why it matters
Potential benefit: If successful, SMO1 could provide an effective alternative to the current dexamethasone implant for RVO-related macular edema.
How similar studies have gone: Previous intravitreal corticosteroid implants have shown benefit in RVO-related edema; this study tests a new implant in a similar setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 19 years of age or older * A study eye diagnosed with macular edema following i) branch retinal vein occlusion (BRVO) within 12 months prior to the screening visit or; ii) central retinal vein occlusion (CRVO) within 9 months prior to the screening visit * A study eye with CRT measured to be 300μm or greater using OCT at the screening visit * A study eye with BCVA between 34 and 68 letters at the screening visit and the baseline (comparable to Snellen score between 20/200 and 20/50) * Provided written informed consent voluntarily after receiving a full explanation of the clinical trial Exclusion Criteria: * A study eye with visual improvement determined to be highly unlikely due to the baseline condition of the eye * A study eye with macular edema caused by the formation of an epiretinal membrane or visual improvement determined to be highly unlikely even if the macular edema decreases * A study eye with uncontrolled glaucoma with intraocular pressure of 25mmHg or higher despite medical treatment at the screening visit * A study eye with severe media opacity such as corneal opacity, cataracts, or vitreous hemorrhage
Where it's running
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Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea Recruiting
Study contacts
- Study coordinator: Nahyun Kang, Ph.D
- Email: nahyun.kang@sminnovation.com
- Phone: +82 2-3489-6298
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.