A Phase 3 interventional study of Dexamethasone and Triamcinolone in Inflammatory Macular Edema, sponsored by Nantes University Hospital. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Phase 3, Interventional, and Treatment
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.
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravitreal implant of 700μg of dexamethasone (Ozurdex®)
Drug: Dexamethasone
Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)
Drug: Triamcinolone
Intravitreal implant at D0
Also known as: Ozurdex®
Subconjunctival injection at 4 mm from the limbus at 6 o'clock
Also known as: Kénacort retard®
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
Time frame: At 2 months after treatment
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)
Time frame: At day 0 (= the day of the treatment)
Evaluation of the effectiveness of the studied injection at each visit regarding gain in visual acuity (ETDRS)
Visual acuity (ETDRS)
Time frame: 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)
Time frame: Up to 6 months
Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze
Vitreous flare
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 6 months
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital