BridgeMD
Tests treatment safety and results for Retinal Vein Occlusion With Macular Edema
Official title Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
ClinicalTrials.gov ID: NCT07708142
What this study is testing
What is Reference Drug?
Reference Drug is an investigational medicine, being studied as a potential treatment for retinal vein occlusion with macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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)...
- 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 likely can't join 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Gangdong-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Gangdong-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.