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New treatment option for Diabetic Macular Edema
Official title EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
ClinicalTrials.gov ID: NCT06536491
What this study is testing
What is EC-104 high dose?
EC-104 high dose is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic 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 prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide [FA] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).
- Phase 2: a mid-size study of how well it works
- 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 18 and older
You may be able to join if
- Males or females who are at least 18 years of age at the time of informed consent
- Willing and able to provide signed informed consent (participant or legally authorized representative) prior to any study-related procedures and to...
- Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) \< = years duration prior to Screening Visit 1
- Currently monitored hemoglobin A1c values ≤ 10.0 while under the care of a qualified medical provider for diabetes mellitus management, unless...
- Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20/40 or worse) and ≥ 20 letters (Snellen equivalent 20/400)...
You likely can't join if
- Previous or current diagnosis of any form of glaucoma (defined as cup-to-disc ratio \> 0.7) or ocular hypertension (documented intraocular pressure...
- History of steroid-induced IOP elevation \> 25 mm Hg
- Presence of active proliferative diabetic retinopathy, defined as active neovascularization of disc (NVD), neovascularization elsewhere (NVE)...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. 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.