Back to resultsEfficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema (TRIOZ)
Primary Purpose
Inflammatory Macular Edema
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dexamethasone
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Macular Edema focused on measuring Ophthalmology, Uveitic macular edema, Triamcinolone subconjunctival injection, Dexamethasone intraocular implant
Eligibility Criteria
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")
Sites / Locations
- CHU Angers
- CHU de Bordeaux
- CHU de Brest
- CHU de Dijon
- CHU de Grenoble
- Hôpital Bicêtre (AP-HP)
- CHRU de Lille
- Hopices Civils de Lyon
- CHU de Montpellier
- CHU de Nantes
- CHU de Nice
- Hôpital La Pitié-Salpêtrière (AP-HP)
- Fondation Ophtalmologique Adolphe de Rothschild
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- CHU de Tours
- CHU de Nancy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Reference Drug
Tested Drug
Arm Description
Intravitreal implant of 700μg of dexamethasone (Ozurdex®)
Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS)
Visual acuity (ETDRS)
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)
Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze
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
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)
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
Patients' quality of life questionnaire (EQ-5D)
Full Information
NCT ID
NCT02556424
First Posted
May 29, 2015
Last Updated
September 5, 2022
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02556424
Brief Title
Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Acronym
TRIOZ
Official Title
Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Macular Edema
Keywords
Ophthalmology, Uveitic macular edema, Triamcinolone subconjunctival injection, Dexamethasone intraocular implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference Drug
Arm Type
Active Comparator
Arm Description
Intravitreal implant of 700μg of dexamethasone (Ozurdex®)
Arm Title
Tested Drug
Arm Type
Experimental
Arm Description
Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Ozurdex®
Intervention Description
Intravitreal implant at D0
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Kénacort retard®
Intervention Description
Subconjunctival injection at 4 mm from the limbus at 6 o'clock
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
At 2 months after treatment
Secondary Outcome Measure Information:
Title
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)
Description
Scale of "patient experience" the day of the injection (tolerable, unpleasant, very unpleasant) and visual analogue scale (VAS)
Time Frame
At day 0 (= the day of the treatment)
Title
Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS)
Description
Visual acuity (ETDRS)
Time Frame
Up to 6 months
Title
Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the anterior flare
Description
Anterior flare ("Lampe A Fente" and Laser Flare Meter, if available)
Time Frame
Up to 6 months
Title
Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze
Description
Vitreous flare
Time Frame
Up to 6 months
Title
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
Description
Central macular thickness of the eye treated for determining the duration of action
Time Frame
Up to 6 months
Title
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)
Description
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
Time Frame
Up to 6 months
Title
Evaluation of the effectiveness of the studied injection at each visit regarding patients' quality of life
Description
Patients' quality of life questionnaire (EQ-5D)
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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")
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital Bicêtre (AP-HP)
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital La Pitié-Salpêtrière (AP-HP)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU de Nancy
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54500
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32041669
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
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