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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556424
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE September 22, 2015
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
  • 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)
  • 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) Visual acuity (ETDRS)
  • 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)
  • 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
  • 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
  • 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
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Official Title  ICMJE Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Brief 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. 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inflammatory Macular Edema
Intervention  ICMJE
  • Drug: Dexamethasone
    Intravitreal implant at D0
    Other Name: Ozurdex®
  • Drug: Triamcinolone
    Subconjunctival injection at 4 mm from the limbus at 6 o'clock
    Other Name: Kénacort retard®
Study Arms  ICMJE
  • Active Comparator: Reference Drug
    Intravitreal implant of 700μg of dexamethasone (Ozurdex®)
    Intervention: Drug: Dexamethasone
  • Experimental: Tested Drug
    Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)
    Intervention: Drug: Triamcinolone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 23, 2020)
114
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2015)
142
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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")
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02556424
Other Study ID Numbers  ICMJE RC15_0056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP