Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
Recruiting
Phase 3
Interventional Study
Retinal Vein Occlusion With Macular Edema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 312 (estimated)
- Sponsor
- SANGMYUNG innovation · Industry
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About This Trial
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 re…
Trial Locations
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Eligibility 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…
Contacts