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Eye implant could restore sight after retinal vein blockage

NCT ID NCT07708142

Disease control Sponsor: SANGMYUNG innovation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 3 trial tests a single injection of SMO1, a dexamethasone implant placed inside the eye, for people with macular edema (swelling) caused by a blocked retinal vein. The study compares SMO1 to an existing dexamethasone implant to see which better improves vision and reduces swelling over six months. Participants are adults with branch or central retinal vein occlusion and significant vision loss. The goal is to find a safe, effective treatment to help restore sight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a dexamethasone intravitreal implant (SMO1)
What this could lead to
If successful, SMO1 could offer a new treatment option for people with vision loss due to retinal vein occlusion, potentially improving sight with a single injection.
What could go wrong
This is a phase 3 trial comparing SMO1 to an existing drug, so it may not prove superior. Eye injections carry risks like infection, increased eye pressure, or cataract formation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

central retinal vein occlusion with macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinal vein occlusion with macular edema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kyung Hee University Hospital at Gangdong

    RECRUITING

    Seoul, Gangdong-gu, 05278, South Korea