Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema (LOADEX)

Inclusion Criteria:

• Patient > 40 years old

• Patients with a significant DME : Macular thickening secondary to DME involving thecenter 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, atscreening and VA between 20/32 and 20/320 (between 23 and 78 letters ETDRS) usingthe 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 thelowest visual acuity at the baseline

Exclusion Criteria:

• Aphatic eye without posterior lens capsule.

• Study eye with implant anterior chamber of the eye or intraocular implant with irisfixated 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 mostviral diseases of the cornea and conjunctiva, epithelial keratitis active Herpessimplex (dendritic keratitis), vaccinia, chickenpox, mycobacterial infections andmycoses

• At inclusion, delay after cataract surgery < 3 months in the study eye

• Delay after last session of panretineal Photocoagulation laser < 1 month in thestudy eye

• Delay after last focal laser session of the posterior pole < 1 month in the studyeye

• 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 (1/2Papillary Diameter) in the study eye

• Ischemic maculopathy (increase of more than 2 times the surface of the centralavascular 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 theDiabetic Macular Edema and treated by with immunosuppressive drugs, systemicsteroids, anti-aldosterone or systemic anti-VEGF.

• Patients with systemic treatment with a toxic effect on the lens, retina or opticnerve: deferoxime, chloroquine / hydroxychloroquine, tamoxifen, phenothiazines andethambutol; in progress or within 6 months of inclusion

• Hypersensitivity to the active substance or to any of the excipients and toanesthetic or hypotonizing eye drops

• History of any pathology, metabolic disease, or any serious suspicion of disease atclinical or laboratory examination that contraindicates the use of the intra-retinaldexamethasone implant, could affect the interpretation of the results of the studyor 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 requireintraocular 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 usingadequate and highly effective contraception during the study and up to 6 monthsafter the last administration of the study treatment:

• Combined hormonal contraception (containing estrogens and progestins) aimed atinhibiting ovulation (oral, intravaginal or transdermal);

• Hormonal contraception containing only a progestin intended to inhibitovulation (oral, injectable or implantable);

• Intrauterine device (IUD);

• Intrauterine Hormone Release System (IUS);

• Ovariectomy with hysterectomy, bilateral tubal obstruction or totalhysterectomy for at least 6 weeks before inclusion (for women included) orvasectomy for at least 6 months before inclusion (for partners of a patientincluded);

• Sexual abstinence. A woman will be considered to be of childbearing age fromher first period and until the menopause, unless she is sterile or has had anoophorectomy type surgery with hysterectomy, bilateral tubal obstruction orhysterectomy total at least 6 weeks before inclusion. A post-menopausal stateis defined as the absence of spontaneous menstruation (that is to say withoutany other medical treatment, in particular of the hormonal contraceptive typeor 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 eyeand/or untreated eye)

• Follow-up impossible for 24 months, the judgment of the investigator.