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

September 5, 2022 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Bordeaux, France, 33076
        • CHU de Bordeaux
      • Brest, France, 29609
        • CHU de Brest
      • Dijon, France, 21079
        • CHU de Dijon
      • La Tronche, France, 38700
        • CHU de Grenoble
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre (AP-HP)
      • Lille, France, 59037
        • CHRU de Lille
      • Lyon, France, 69004
        • Hopices Civils de Lyon
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Nantes, France, 44093
        • CHU de Nantes
      • Nice, France, 06000
        • CHU de Nice
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Paris, France, 75013
        • Hôpital La Pitié-Salpêtrière (AP-HP)
      • Paris, France, 75571
        • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
      • Tours, France, 37044
        • CHU de Tours
      • Vandoeuvre-les-Nancy, France, 54500
        • CHU de NANCY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reference Drug
Intravitreal implant of 700μg of dexamethasone (Ozurdex®)
Drug: Dexamethasone
Intravitreal implant at D0
Other Names:
  • Ozurdex®
Experimental: Tested Drug
Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)
Drug: Triamcinolone
Subconjunctival injection at 4 mm from the limbus at 6 o'clock
Other Names:
  • Kénacort retard®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
At 2 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: At day 0 (= the day of the treatment)
Scale of "patient experience" the day of the injection (tolerable, unpleasant, very unpleasant) and visual analogue scale (VAS)
At day 0 (= the day of the treatment)
Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS)
Time Frame: Up to 6 months
Visual acuity (ETDRS)
Up to 6 months
Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the anterior flare
Time Frame: Up to 6 months
Anterior flare ("Lampe A Fente" and Laser Flare Meter, if available)
Up to 6 months
Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze
Time Frame: Up to 6 months
Vitreous flare
Up to 6 months
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
Time Frame: Up to 6 months
Central macular thickness of the eye treated for determining the duration of action
Up to 6 months
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)
Time Frame: Up to 6 months
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
Up to 6 months
Evaluation of the effectiveness of the studied injection at each visit regarding patients' quality of life
Time Frame: Up to 6 months
Patients' quality of life questionnaire (EQ-5D)
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC15_0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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