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Eye injection vs. implant: which calms swelling better?

NCT ID NCT02556424

Disease control Sponsor: Nantes University Hospital 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers compare two corticosteroid treatments for inflammatory macular edema, a condition where swelling in the center of the retina blurs vision. Adults with the condition receive either a subconjunctival injection of triamcinolone or an intravitreal implant of dexamethasone. The trial measures how much each treatment reduces central macular thickness after two months and asks patients how tolerable the injection experience feels.

What this could mean

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

Active substance
triamcinolone acetonide injection and dexamethasone intravitreal implant
What this could lead to
If one approach proves better, doctors could choose the more effective and comfortable corticosteroid treatment for inflammatory macular edema.
What could go wrong
Both treatments are already used, so the trial may show similar results. Injections and implants carry risks of eye infection, bleeding, or raised eye pressure, and the trial may not settle which option is best for every patient.

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

114 people

The number who actually took part.

Started

Jan 2016

Finished

Feb 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patient, male or female (under effective contraception if premenopausal) over 18 years old * Patient affiliated with a social security plan * Patient able to understand and follow the instructions of the study * Patient having signed an informed consent * Patient having a central macular thickness greater than 320μm (Spectral Domain, 270µm Time Domain) * Patient with an inflammatory macular edema, unilateral or bilateral (in the case of a bilateral inflammatory macular edema, the eye most affected will be treated) Exclusion Criteria: * Patient with an infectious uveitis * Patient with uncontrolled active infection * Patient receiving an unbalanced general anti-inflammatory and/or immunosuppressive and/or immunomodulatory therapy (recent modification \<1 month) * Patient having a history of glaucoma and/or ocular hypertension in the eye studied (intraocular pressure (IOP) \> 25 mmHg without antiglaucoma medication or \> 21 mmHg with antiglaucoma combination therapy) and/or cortisone-causing-hypertension not controlled by an antiglaucoma dual therapy * Patient with uncontrolled diabetes (HbA1c\> 8%) or unbalanced hypertension (Systolic Blood Pressure \> 160 mmHg and/or Diastolic Blood Pressure \> 100mmHg) * Edematous diabetic maculopathy * Patient who had received triamcinolone (subconjunctivally or sub-tenon) 3 months before randomization, or 700μg dexamethasone intravitreally 6 months before randomization * Suspected or active ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, such as active epithelial keratitis with herpes simplex (dendritic keratitis), vaccinia, varicella, mycobacterial infections and mycoses * History of ocular herpes infection or central serous chorioretinopathy * Aphakic eye with rupture of the posterior lens capsule * Eye with implant in the anterior chamber, iris- or transscleral-fixated intraocular implant and rupture of the posterior lens capsule * Uncontrolled systemic inflammatory disease. * Known hypersensitivity to the active substance or to one of the excipients of Ozurdex®, Kenacort® or injectable fluorescein * Pregnant woman or likely to become pregnant or nursing * Patient participating in another clinical trial * Adult under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")

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Conditions

The condition(s) this trial relates to.

macular retinal edema

As listed by the trial registrant

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

Inflammatory macular edema

Contacts and locations

Locations

  • CHRU de Lille

    Lille, 59037, France

  • CHU Angers

    Angers, France

  • CHU de Bordeaux

    Bordeaux, 33076, France

  • CHU de Brest

    Brest, 29609, France

  • CHU de Dijon

    Dijon, 21079, France

  • CHU de Grenoble

    La Tronche, 38700, France

  • CHU de Montpellier

    Montpellier, 34295, France

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Nice

    Nice, 06000, France

  • CHU de Tours

    Tours, 37044, France

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    Paris, 75571, France

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris, 75019, France

  • Hopices Civils de Lyon

    Lyon, 69004, France

  • Hôpital Bicêtre (AP-HP)

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital La Pitié-Salpêtrière (AP-HP)

    Paris, 75013, France