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Inflammatory Macular EdemaPhase 3TRIOZNCT02556424

Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema

A Phase 3 study testing Dexamethasone and Triamcinolone in people with Inflammatory Macular Edema, run by Nantes University Hospital at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Macular Edema
What is being tested?
Dexamethasone and Triamcinolone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
16 sitesFrance
Study dates
Jan 2016to 15 Feb 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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")

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHU Angers

    Angers

  • CHU de Bordeaux

    Bordeaux, 33076

  • CHU de Brest

    Brest, 29609

  • CHU de Dijon

    Dijon, 21079

  • CHU de Grenoble

    La Tronche, 38700

  • Hôpital Bicêtre (AP-HP)

    Le Kremlin-Bicêtre, 94270

  • CHRU de Lille

    Lille, 59037

  • Hopices Civils de Lyon

    Lyon, 69004

  • CHU de Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44093

  • CHU de Nice

    Nice, 06000

  • Hôpital La Pitié-Salpêtrière (AP-HP)

    Paris, 75013

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris, 75019

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    Paris, 75571

  • CHU de Tours

    Tours, 37044

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label.

In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.

Read the detailed description

This research compares the implantation techniques of corticosteroids in the eye, with two groups of equal size being followed. This is a multi-center, controlled study, with the reference drug being the intravitreal implant of 700μg of dexamethasone (Ozurdex®) compared to subconjunctival injection of triamcinolone (Kénacort retard®). This is an open, prospective, randomized study. It is not possible, for technical reasons, to inject blind two products with different injection routes and that are visible to the investigator during control examinations (sub-conjunctival crystals and intravitreal implant). However, the assessment of visual acuity and central macular thickness will be performed by an uninformed ophthalmologist.

Being tested
Dexamethasone, Triamcinolone
Keywords
Ophthalmology, Uveitic macular edema, Triamcinolone subconjunctival injection, Dexamethasone intraocular implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Ozurdex®

    Intravitreal implant at D0

  • TriamcinoloneDrug

    Also called Kénacort retard®

    Subconjunctival injection at 4 mm from the limbus at 6 o'clock

Study groups in NCT02556424
Study groupRoleWhat they receive
Reference DrugActive comparatorIntravitreal implant of 700μg of dexamethasone (Ozurdex®)
Receives: Drug: Dexamethasone
Tested DrugExperimentalSubconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)
Receives: Drug: Triamcinolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment

    Difference of the central macular thickness in the treated eye, measured by Optical Coherence Tomography (OCT) spectral domain, for each patient between patient selection and 2 months after treatment

    Measured: At 2 months after treatment

Secondary outcomes (7)

  1. Evaluation of the experience of the injection by a questionnaire (tolerable, unpleasant and very unpleasant) and by EVA (0 cm = no pain to 10 cm = extreme pain)

    Scale of "patient experience" the day of the injection (tolerable, unpleasant, very unpleasant) and visual analogue scale (VAS)

    Measured: At day 0 (= the day of the treatment)

  2. Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS)

    Visual acuity (ETDRS)

    Measured: Up to 6 months

  3. Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the anterior flare

    Anterior flare ("Lampe A Fente" and Laser Flare Meter, if available)

    Measured: Up to 6 months

  4. Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze

    Vitreous flare

    Measured: Up to 6 months

  5. Evaluation of the effectiveness of the studied injection at each visit regarding central macular thickness measured by OCT, allowing the evaluation of the duration of action of the treatment

    Central macular thickness of the eye treated for determining the duration of action

    Measured: Up to 6 months

  6. Evaluation of the effectiveness of the studied injection at each visit regarding local and general tolerance, by collecting all Adverse Events (AEs) / Serious Adverse Events (SAEs)

    Evaluation of tolerance by collecting all AEs / SAEs of randomized patients, such as intra-ocular hypertension, cataracts, endophthalmitis, poor glycemic and/or blood pressure control

    Measured: Up to 6 months

  7. Evaluation of the effectiveness of the studied injection at each visit regarding patients' quality of life

    Patients' quality of life questionnaire (EQ-5D)

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion15 Feb 2021
  4. Study completion15 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02556424
Sponsor's protocol ID
RC15_0056
Acronym
TRIOZ
Status last verified
Oct 2020
First submitted
29 May 2015
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Couret C, Poinas A, Volteau C, Riche VP, Le Lez ML, Errera MH, Creuzot-Garcher C, Baillif S, Kodjikian L, Ivan C, Le Jumeau de Kergaradec LM, Chiffoleau A, Jobert A, Jaulin J, Biron L, Hervouet E, Weber M. Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial. Trials. 2020 Feb 10;21(1):159. doi: 10.1186/s13063-020-4066-0.

    PubMed 32041669

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone and Triamcinolone in people with Inflammatory Macular Edema, run by Nantes University Hospital at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment (time frame: At 2 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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