Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema

Phase 3RecruitingNCT07708142

SANGMYUNG innovation312 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

312

Conditions

Retinal Vein Occlusion With Macular Edema

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Best corrected visual acuity (BCVA) at 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

Time frame: Month 2

Secondary Outcomes

BCVA at 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

Time frame: Month 1, 3, and 6

BCVA improvement of 15 letters (3 lines) or more

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)

Time frame: Month 1, 2, 3, and 6

Central retinal thickness (CRT) at each visit

Change in CRT compared to the baseline measured with optical coherence tomography (OCT), at each post-administration visit (Month 1, 2, 3, and 6)