Informations générales (source: ClinicalTrials.gov)
Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema (LOADEX)
Interventional
Phase 2
Hospices Civils de Lyon (Voir sur ClinicalTrials)
novembre 2020
décembre 2026
07 août 2024
Nowadays, steroids and anti-VEGF are the first line treatment for diabetic macular edema.
Ozurdex is the most frequently used steroid and has label for both first and second line
treatment. Ozurdex treatment paradigm for patients with diabetic macular edema is to
inject patient only in case of huge recurrence. The risk of this scheme is a progressive
loss of vision due to photoreceptors loss. A more pro-active regimen, as it already
exists for anti-VEGF treatment, would allow a better patient management. A new treatment
paradigm consisting in a loading dose of 2 injections within 12 weeks, followed by a PRN
(Pro Re Nata) regimen with strict retreatment criteria and minimal time limit of 12 weeks
between two injections should result in a better visual acuity gain and a limited
augmentation of the number of injections (which will remain lower than the number
observed for anti-VEGF treatment).
The investigators have therefore chosen a pilot study to investigate the impact on
efficacy and on the number of intravitreal injections (IVI) of such a scheme.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED | 29/03/2024 01:29:12 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Francine BEHAR-COHEN | Contact (sur clinicalTrials) | |||
| CHNO DES QUINZE-VINGTS PARIS | R ADAM | Contact (sur clinicalTrials) | |||
| HOPITAL FONDATION A. DE ROTHSCHILD | Audrey GIOCANTI-AUREGAN | vendredi 21 juin 2024 | Contact (sur clinicalTrials) | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospices Civils de Lyon - Hopital de la Croix Rousse - 69004 - Lyon - France | Laurent KODJIKIAN | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hôpital Nord - 13015 - Marseille - France | Alban COMET | Contact (sur clinicalTrials) | |||
| APHP - Hôpital La Pitié Salpetrière - 75013 - Paris - France | Sarah TOUHAMI | Contact (sur clinicalTrials) | |||
| APHP - Hôpital Lariboisière - 75010 - Paris - France | Aude COUTURIER | Contact (sur clinicalTrials) | |||
| Cabinet du Dr DUCOS DE LAHITTE - Quint-Fonsegrives - France | Ghislaine DUCOS DE LAHITTE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Intercommunal Toulon - La Seyne-sur-Mer - France | Magali SAMPO | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Simone Veil Eaubonne SITE D'EAUBONNE - Eaubonne - France | Pierre-Antoine FORTE | Contact (sur clinicalTrials) | |||
| Centre Monticelli Paradis d'ophtalmologie - 13008 - Marseille - France | Frédéric MATONTI | Contact (sur clinicalTrials) | |||
| Centre Rétine Gallien - Bordeaux - France | Laurence ROSIER | Contact (sur clinicalTrials) | |||
| CH Henri Duffaut - 84000 - Avignon - France | Caroline MARC | Contact (sur clinicalTrials) | |||
| CHRU Lille - Hôpital Huriez - 59037 - Lille - France | Pierre LABALETTE | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Hôpital Pellegrin - 33000 - Bordeaux - France | Marie-Noëlle DELYFER | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - La miletrie - 86000 - Poitiers - France | Nicolas LEVEZIEL | Contact (sur clinicalTrials) | |||
| CHU Dijon - 21079 - Dijon - France | Catherine CREUZOT-GARCHER | Contact (sur clinicalTrials) | |||
| CHU Nice - Hôpital Pasteur 2 - 06000 - Nice - France | Stéphanie BAILLIF | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Hôpital Pierre Paul Riquet - 31059 - Toulouse - France | Fanny VARENNE | Contact (sur clinicalTrials) | |||
| Clinique du Val d'Ouest - Centre Ophtalmologique Pôle Vision - Ecully - France | CORNUT Pierre Loic | Contact (sur clinicalTrials) | |||
| Clinique Juge - Marseille - France | Frédéric MATONTI | Contact (sur clinicalTrials) | |||
| Clinique Mathilde - Rouen - France | Joel UZZAN | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - 69003 - Lyon - France | Corinne DOT | Contact (sur clinicalTrials) | |||
| Polyclinique du Parc - Caen & Cabinet Ophtalmologie Dr Rysanek - Caen - France | Boris RYSANEK | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient > 40 years old
- Patients with a significant DME : Macular thickening secondary to DME involving the
center of the fovea, as measured by SD-OCT, with Central Subfield Thickness (CST) ≥
285 μm measured on Spectralis/topcon or ≥ 275 μm, as measured on Cirrus, at
screening and VA between 20/32 and 20/320 (between 23 and 78 letters ETDRS) using
the ETDRS protocol at the initial testing distance of 4 meters at inclusion
- Patient for which a dexamethasone implant is chosen
- 100% naive eyes (no history of steroids or anti-VEGF)
- Pseudophakic for at least 3 months
- HBA1c < 10%
- Blood pressure < 160/95
- Patient who give voluntary signed informed consent
- Patient affiliated with the French universal health care system or similar
- Patient able to participated in all visits and medical examinations during the study
- If both eyes have to be treated, only one eye will be included : the eye with the
lowest visual acuity at the baseline
- Patient > 40 years old
- Patients with a significant DME : Macular thickening secondary to DME involving the
center of the fovea, as measured by SD-OCT, with Central Subfield Thickness (CST) ≥
285 μm measured on Spectralis/topcon or ≥ 275 μm, as measured on Cirrus, at
screening and VA between 20/32 and 20/320 (between 23 and 78 letters ETDRS) using
the ETDRS protocol at the initial testing distance of 4 meters at inclusion
- Patient for which a dexamethasone implant is chosen
- 100% naive eyes (no history of steroids or anti-VEGF)
- Pseudophakic for at least 3 months
- HBA1c < 10%
- Blood pressure < 160/95
- Patient who give voluntary signed informed consent
- Patient affiliated with the French universal health care system or similar
- Patient able to participated in all visits and medical examinations during the study
- If both eyes have to be treated, only one eye will be included : the eye with the
lowest visual acuity at the baseline
- Aphatic eye without posterior lens capsule.
- Study eye with implant anterior chamber of the eye or intraocular implant with iris
fixated or transsclerally or ruptured posterior lens capsule.
- Study eye with lens implant ARTISAN®
- Ocular or periocular infection active or suspected in the study eye including most
viral diseases of the cornea and conjunctiva, epithelial keratitis active Herpes
simplex (dendritic keratitis), vaccinia, chickenpox, mycobacterial infections and
mycoses
- At inclusion, delay after cataract surgery < 3 months in the study eye
- Delay after last session of panretineal Photocoagulation laser < 1 month in the
study eye
- Delay after last focal laser session of the posterior pole < 1 month in the study
eye
- Vitreomacular traction syndrome, associated ERM in the study eye
- History of macular grid laser in the study eye
- Focal laser only if the scars are located within 750 microns of the center (1/2
Papillary Diameter) in the study eye
- Ischemic maculopathy (increase of more than 2 times the surface of the central
avascular zone)
- Proliferative diabetic Retinopathy in the study eye
- Hypertension or Open Angle Glaucoma (OAG) treated by dual therapy eye drops or more
- Patients with a systemic pathology that could interfere in the evolution of the
Diabetic Macular Edema and treated by with immunosuppressive drugs, systemic
steroids, anti-aldosterone or systemic anti-VEGF.
- Patients with systemic treatment with a toxic effect on the lens, retina or optic
nerve: deferoxime, chloroquine / hydroxychloroquine, tamoxifen, phenothiazines and
ethambutol; in progress or within 6 months of inclusion
- Hypersensitivity to the active substance or to any of the excipients and to
anesthetic or hypotonizing eye drops
- History of any pathology, metabolic disease, or any serious suspicion of disease at
clinical or laboratory examination that contraindicates the use of the intra-retinal
dexamethasone implant, could affect the interpretation of the results of the study
or cause significant risks of complication for the subject
- Infectious conjunctivitis and/or active or suspected appendix infection
- Any eye condition or condition that the investigator believes may require
intraocular surgery within 12 months
- Eye contralateral that studied with visual acuity < 23 letters
- Pregnant and breastfeeding woman
- Female of reproductive age, sexually active, who does not want to commit to using
adequate and highly effective contraception during the study and up to 6 months
after the last administration of the study treatment:
- Combined hormonal contraception (containing estrogens and progestins) aimed at
inhibiting ovulation (oral, intravaginal or transdermal);
- Hormonal contraception containing only a progestin intended to inhibit
ovulation (oral, injectable or implantable);
- Intrauterine device (IUD);
- Intrauterine Hormone Release System (IUS);
- Ovariectomy with hysterectomy, bilateral tubal obstruction or total
hysterectomy for at least 6 weeks before inclusion (for women included) or
vasectomy for at least 6 months before inclusion (for partners of a patient
included);
- Sexual abstinence. A woman will be considered to be of childbearing age from
her first period and until the menopause, unless she is sterile or has had an
oophorectomy type surgery with hysterectomy, bilateral tubal obstruction or
hysterectomy total at least 6 weeks before inclusion. A post-menopausal state
is defined as the absence of spontaneous menstruation (that is to say without
any other medical treatment, in particular of the hormonal contraceptive type
or hormone replacement therapy) for 12 months
- Major patient protected under the terms of the law (Public Health Code)
- Patient's ongoing participation in another interventional clinical trial (study eye
and/or untreated eye)
- Follow-up impossible for 24 months, the judgment of the investigator.