Clinical trial NCT02556424: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Macular Edema
Keywords: Ophthalmology
Uveitic macular edema
Triamcinolone subconjunctival injection
Dexamethasone intraocular implant
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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")

Primary outcomes:
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
timeFrame: At 2 months after treatment
Secondary outcomes:
measure: 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)
timeFrame: At day 0 (= the day of the treatment)
measure: Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS)
timeFrame: Up to 6 months
measure: Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the anterior flare
timeFrame: Up to 6 months
measure: Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 6 months
measure: 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)
timeFrame: Up to 6 months
measure: Evaluation of the effectiveness of the studied injection at each visit regarding patients' quality of life
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Dijon
country: France
facility: CHU de Dijon
city: La Tronche
country: France
facility: CHU de Grenoble
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre (AP-HP)
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Hopices Civils de Lyon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière (AP-HP)
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
city: Tours
country: France
facility: CHU de Tours
city: Vandoeuvre-les-Nancy
country: France
facility: CHU de Nancy
Study officials:
References:
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.