Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema

NCT02556424 | Completed Phase 3 DMC

• 1 other identifier: RC15_0056
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 16

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.

Conditions

Inflammatory Macular Edema

Keywords

Ophthalmology; Uveitic macular edema; Triamcinolone subconjunctival injection; Dexamethasone intraocular implant

Outcome Measures

Primary Outcomes (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

  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

Secondary Outcomes (7)

• 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)

  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)

  Up to 6 months

• Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the anterior flare

  Up to 6 months

• Evaluation of the effectiveness of the studied injection at each visit regarding reduction of the vitreous haze

  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

  Up to 6 months

Study Arms (2)

Reference Drug

ACTIVE COMPARATOR

Intravitreal implant of 700μg of dexamethasone (Ozurdex®)

Drug: Dexamethasone

Tested Drug

EXPERIMENTAL

Subconjunctival injection of 16 mg triamcinolone (Kénacort Retard®)

Drug: Triamcinolone

Interventions

Dexamethasone DRUG

Intravitreal implant at D0

Also known as: Ozurdex®

Reference Drug

Triamcinolone DRUG

Subconjunctival injection at 4 mm from the limbus at 6 o'clock

Also known as: Kénacort retard®

Tested Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (16)

CHU Angers

Angers, France

Location

CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU de Brest

Brest, 29609, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Grenoble

La Tronche, 38700, France

Location

Hôpital Bicêtre (AP-HP)

Le Kremlin-Bicêtre, 94270, France

Location

CHRU de Lille

Lille, 59037, France

Location

Hopices Civils de Lyon

Lyon, 69004, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06000, France

Location

Hôpital La Pitié-Salpêtrière (AP-HP)

Paris, 75013, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75571, France

Location

CHU de Tours

Tours, 37044, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• 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.

  PMID: 32041669 DERIVED

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: September 22, 2015
• Study Start: January 1, 2016
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: September 7, 2022

Record last verified: 2020-10

Locations

FR (16)