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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Drug | Active Comparator | Intravitreal implant of 700μg of dexamethasone (Ozurdex®) |
|
| Tested Drug | Experimental | Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intravitreal implant at D0 |
|
|
| 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 | 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 |
| 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU de Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32041669 | Derived | 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. |
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| Triamcinolone | Drug | Subconjunctival injection at 4 mm from the limbus at 6 o'clock |
|
|
| Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS) |
Visual acuity (ETDRS) |
| Up to 6 months |
| 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) | Up to 6 months |
| Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze | 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 | 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) | 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 | Patients' quality of life questionnaire (EQ-5D) | Up to 6 months |
| Bordeaux |
| 33076 |
| France |
| CHU de Brest | Brest | 29609 | France |
| CHU de Dijon | Dijon | 21079 | France |
| CHU de Grenoble | La Tronche | 38700 | France |
| Hôpital Bicêtre (AP-HP) | Le Kremlin-Bicêtre | 94270 | France |
| CHRU de Lille | Lille | 59037 | France |
| Hopices Civils de Lyon | Lyon | 69004 | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHU de Nantes | Nantes | 44093 | France |
| CHU de Nice | Nice | 06000 | France |
| Hôpital La Pitié-Salpêtrière (AP-HP) | Paris | 75013 | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Paris | 75571 | France |
| CHU de Tours | Tours | 37044 | France |
| CHU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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