Retinal Vein Occlusion With Macular EdemaPhase 3NCT07708142
Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
A Phase 3 study testing Reference Drug and SMO1 in people with Retinal Vein Occlusion With Macular Edema, run by SANGMYUNG innovation at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Retinal Vein Occlusion With Macular Edema
- What is being tested?
- Reference Drug and SMO1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jan 2026to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, 05278
CRC Park, +82 2-440-7065, messenger012@gmail.com
About this study
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
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.
- Being tested
- Reference Drug, SMO1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference DrugDrug
- 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.
SMO1Drug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | Active comparator | Treatment: Reference Drug (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop Receives: Drug: Reference Drug |
| SMO1 Group | Experimental | Treatment: SMO1 (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop Receives: Drug: SMO1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 2
Secondary outcomes (3)
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
Measured: 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)
Measured: 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)
Measured: Month 1, 2, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start29 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein Occlusion With Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SANGMYUNG innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708142
- Sponsor's protocol ID
- SMO1-301
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07708142
- Acronym / sponsor ID
- SMO1-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- SANGMYUNG innovationIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Group | Active comparator | Drug: Reference DrugTreatment: Reference Drug (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop |
| SMO1 Group | Experimental | Drug: SMO1Treatment: SMO1 (Dexamethasone 700μg Intravitreal Implant) Pre-treatment: Ofloxacin (3mg/mL) Eye Drop |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference Drug1. 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 | Reference Group |
| SMO11. 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. | Drug | SMO1 Group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reference Drug and SMO1 in people with Retinal Vein Occlusion With Macular Edema, run by SANGMYUNG innovation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahyun Kang, Ph.D (+82 2-3489-6298, nahyun.kang@sminnovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) at Month 2 (time frame: Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.