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NCT Number: NCT07708142

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

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.

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Key information

Conditions

Retinal Vein Occlusion With Macular Edema

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

Location status: Recruiting

Location contact

CRC Park

CONTACT

[email protected]

+82 2-440-7065

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reference Drug

Drug
  • Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 ~ 3).
  • Single administration of the reference drug at Day 0.

SMO1

Drug
  • 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 outcomes

  1. Best corrected visual acuity (BCVA) at Month 2

    Time frame: 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 outcomes

  1. BCVA at Month 1, 3, and 6

    Time frame: 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

  2. BCVA improvement of 15 letters (3 lines) or more

    Time frame: 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)

  3. Central retinal thickness (CRT) at each visit

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nahyun Kang, Ph.D

CONTACT

[email protected]

+82 2-3489-6298

Sponsors and collaborators

Lead sponsor

SANGMYUNG innovation

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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