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Eye implant takes aim at diabetic macular edema

NCT ID NCT06536491

Disease control Sponsor: Eclipse Life Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing two doses of an experimental eye implant called EC-104 against the standard Ozurdex implant in adults with diabetic macular edema. The trial enrolls people whose swelling did not improve enough with anti-VEGF injections but who have tolerated steroid eye treatments without a significant rise in eye pressure. The main goal is to compare safety, while also tracking how long it takes for the macular edema to return.

What this could mean

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

Active substance
EC-104, a slow-release fluocinolone acetonide implant placed inside the eye
What this could lead to
If it works, EC-104 could offer a longer-lasting implant option for diabetic macular edema in people who do not get enough benefit from standard anti-VEGF injections.
What could go wrong
This is an early phase 2 trial with about 75 participants, so safety and effectiveness are still uncertain. Eye implants can raise eye pressure, cause cataracts, or lead to infection, and the trial may not show a clear advantage over Ozurdex.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 75 people

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

Started

Aug 2024

Expected to finish

Dec 2026

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

18 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: 1. Males or females who are at least 18 years of age at the time of informed consent 2. Willing and able to provide signed informed consent (participant or legally authorized representative) prior to any study-related procedures and to comply with all study visits and cooperate with all examinations 3. Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) \< = years duration prior to Screening Visit 1 4. Currently monitored hemoglobin A1c values ≤ 10.0 while under the care of a qualified medical provider for diabetes mellitus management, unless provider allows value variance Inclusion criteria for the study eye (all of the below criteria must be met in the same eye): 5. Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20/40 or worse) and ≥ 20 letters (Snellen equivalent 20/400) in at least 1 eye Exclusion Criteria: 1. Previous or current diagnosis of any form of glaucoma (defined as cup-to-disc ratio \> 0.7) or ocular hypertension (documented intraocular pressure (IOP) \> 21 mm Hg without glaucomatous disc damage) requiring medical or surgical intervention 2. History of steroid-induced IOP elevation \> 25 mm Hg 3. Presence of active proliferative diabetic retinopathy, defined as active neovascularization of disc (NVD), neovascularization elsewhere (NVE), neovascularization of iris (NVI), neovascularization of angle (NVA), or vitreous hemorrhage in the setting of active NVD or NVE

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

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

Diabetic macular edema

Contacts and locations

Locations

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609, United States

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