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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)

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ClinicalTrials.gov Identifier: NCT02556424
Recruitment Status : Unknown
Verified September 2016 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : September 22, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Inflammatory Macular Edema Drug: Dexamethasone Drug: Triamcinolone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Study Start Date : January 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Active Comparator: Reference Drug
Intravitreal implant of 700μg of dexamethasone (Ozurdex®)
Drug: Dexamethasone
Intravitreal implant at D0
Other Name: 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 Name: Kénacort retard®




Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  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) [ 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)

  2. 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)

  3. 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)

  4. 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

  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 [ Time Frame: Up to 6 months ]
    Central macular thickness of the eye treated for determining the duration of action

  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) [ 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

  7. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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")

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556424


Contacts
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Contact: Weber Michel, MD (0)2 40 48 34 06 ext +33 michel.weber@chu-nantes.fr
Contact: Couret Chloé, MD chloe.couret@chu-nantes.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Marie-Bénédicte Rougier, MD         
CHU de Brest Recruiting
Brest, France, 29609
Contact: Catherine Cochard, MD         
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Catherine Creuzot-Garcher, MD         
CHU de Grenoble Recruiting
La Tronche, France, 38700
Contact: Christophe Chiquet, MD         
Hôpital Bicêtre (AP-HP) Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Marc Labetoulle, MD         
CHRU de Lille Recruiting
Lille, France, 59037
Contact: Pierre Labalette, MD         
Hopices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Laurent Kodjikian, MD         
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Frédéric Mura, MD         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Michel Weber, MD         
Contact: Chloé Couret, MD         
CHU de Nice Recruiting
Nice, France, 06000
Contact: Stéphanie Baillif, MD         
Hôpital La Pitié-Salpêtrière (AP-HP) Recruiting
Paris, France, 75013
Contact: Bahram Bodaghi, MD         
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Isabelle Cochereau, MD         
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts Recruiting
Paris, France, 75571
Contact: Marie-Hélène Errera, MD         
CHU de Tours Recruiting
Tours, France, 37044
Contact: Marie-Laure Le Lez, MD         
CHU de Nancy Recruiting
Vandoeuvre-les-Nancy, France, 54500
Contact: Karine Angioi, MD         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02556424     History of Changes
Other Study ID Numbers: RC15_0056
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Nantes University Hospital:
Ophthalmology
Uveitic macular edema
Triamcinolone subconjunctival injection
Dexamethasone intraocular implant

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors