Retinal Vein Occlusion With Macular Edema
Conditions
Brief 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.
Interventions
DRUGReference 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.
DRUGSMO1
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.
Sponsors
SANGMYUNG innovation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity (BCVA) at Month 2 | Month 2 | Change in BCVA score from the baseline, at Month 2 after the administration of the investigational drug using early treatment diabetic retinopathy study (ETDRS) chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA at Month 1, 3, and 6 | Month 1, 3, and 6 | Change in BCVA score from the baseline, at Month 1, 3, and 6 after the administration of the investigational drug using ETDRS chart |
| BCVA improvement of 15 letters (3 lines) or more | Month 1, 2, 3, and 6 | Proportion of patients with BCVA improvement of 15 letters (3 lines) or more compared to the baseline using ETDRS chart, at each post-administration visit (Month 1, 2, 3, and 6) |
| Central retinal thickness (CRT) at each visit | Month 1, 2, 3, and 6 | Change in CRT compared to the baseline measured with optical coherence tomography (OCT), at each post-administration visit (Month 1, 2, 3, and 6) |
Countries
South Korea
Contacts
CONTACTNahyun Kang, Ph.D
Outcome results
None listed