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

NCT07708142 | Recruiting Phase 3

• 1 other identifier: SMO1-301
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion With Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

  Month 2

Secondary Outcomes (3)

• BCVA at Month 1, 3, and 6

  Month 1, 3, and 6

• BCVA improvement of 15 letters (3 lines) or more

  Month 1, 2, 3, and 6

• Central retinal thickness (CRT) at each visit

  Month 1, 2, 3, and 6

Study Arms (2)

Reference Group

ACTIVE COMPARATOR

Treatment: Reference Drug (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop

Drug: Reference Drug

SMO1 Group

EXPERIMENTAL

Treatment: SMO1 (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop

Drug: SMO1

Interventions

Reference Drug 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.

Reference Group

SMO1 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 SMO1 at Day 0.

SMO1 Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SANGMYUNG innovation: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

RECRUITING

Central Study Contacts

Nahyun Kang, Ph.D

CONTACT

+82 2-3489-6298; nahyun.kang@sminnovation.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)