Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reference Drug, SMO1.
- Who it may be relevant to
- Registry conditions: Retinal Vein Occlusion With Macular Edema. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug 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. - Drug 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.
Primary outcome measures
- Best corrected visual acuity (BCVA) at Month 2 [Time frame: Month 2]
Secondary outcome measures (3)
- BCVA at Month 1, 3, and 6 [Time frame: Month 1, 3, and 6]
- BCVA improvement of 15 letters (3 lines) or more [Time frame: Month 1, 2, 3, and 6]
- Central retinal thickness (CRT) at each visit [Time frame: Month 1, 2, 3, and 6]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Kyung Hee University Hospital at Gangdong — Seoul
Identifiers
NCT: NCT07708142 · SMO1-301