Eye injection vs. implant: which calms swelling better?
NCT ID NCT02556424
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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114 people
The number who actually took part.
- Started
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Jan 2016
- Finished
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Feb 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU de Lille
Lille, 59037, France
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CHU Angers
Angers, France
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CHU de Bordeaux
Bordeaux, 33076, France
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CHU de Brest
Brest, 29609, France
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CHU de Dijon
Dijon, 21079, France
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CHU de Grenoble
La Tronche, 38700, France
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CHU de Montpellier
Montpellier, 34295, France
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CHU de Nancy
Vandœuvre-lès-Nancy, 54500, France
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CHU de Nantes
Nantes, 44093, France
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CHU de Nice
Nice, 06000, France
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CHU de Tours
Tours, 37044, France
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75571, France
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Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019, France
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Hopices Civils de Lyon
Lyon, 69004, France
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Hôpital Bicêtre (AP-HP)
Le Kremlin-Bicêtre, 94270, France
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Hôpital La Pitié-Salpêtrière (AP-HP)
Paris, 75013, France