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LOADEX: PILOT AND PHASE 2 STUDY OF THE EFFICACY OF A TREATMENT PROTOCOL WITH DEXAMETHASONE IMPLANT LOADING DOSE IN PATIENTS WITH DIABETIC MACULAR EDEMA
EU CTIS ID: 2024-514362-39-00
What this study is testing
To describe the efficacy at 1 year (52 weeks) of a new Ozurdex® intravitreal implant treatment regimen, in terms of visual acuity, in patients with diabetic macular oedema.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient over 40 years old
- Patient willing and able to return for all study clinical visits and to complete all related procedures.
- Patient with significant diabetic macular oedema (DMO): * a central macular thickness (CMT) ≥ 285 μm measured by Spectralis/Topcon SD-OCT (spectral-domain optical coherence tomography), or a CMT ≥ 275 μm measured by Cirrus SD-OCT. * visual acuity between 20/32 and 20/230 (between 23 and 78 letters) measured using the ETDRS scale and complying with the measurement protocol at a distance of 4 metres.
- Patient for which it has been decided to insert an intra-retinal dexamethasone implant
- eye naive to any drug treatment (no previous intravitreal corticosteroid or anti-VEGF treatment)
- patient pseudophakic for at least 3 months
You likely can't join if
- Study eye aphakic with missing posterior lens capsule
- Last session of focal laser treatment of the posterior pole of the study eye < 1 month
- Vitreo-macular traction syndrome associated with an epiretinal membrane in the study eye
- History of laser treatment in the macular grid of the study eye
- Ocular hypertension or open-angle glaucoma of the studied eye treated with at least one dual therapy.
- Patients with systemic pathology likely to interfere with the evolution of DME and treated with immunosuppressants, systemic corticoids, anti-aldosterone, systemic anti-VEGF, etc.
See the full eligibility criteria
Who can join
- Patient over 40 years old
- Patient willing and able to return for all study clinical visits and to complete all related procedures.
- Patient with significant diabetic macular oedema (DMO): * a central macular thickness (CMT) ≥ 285 μm measured by Spectralis/Topcon SD-OCT (spectral-domain optical coherence tomography), or a CMT ≥ 275 μm measured by Cirrus SD-OCT. * visual acuity between 20/32 and 20/230 (between 23 and 78 letters) measured using the ETDRS scale and complying with the measurement protocol at a distance of 4 metres.
- Patient for which it has been decided to insert an intra-retinal dexamethasone implant
- eye naive to any drug treatment (no previous intravitreal corticosteroid or anti-VEGF treatment)
- patient pseudophakic for at least 3 months
- HBA1c < 10%
- blood pressure <160/95 mmHg
- Patient who have given their free, informed and signed consent
- Patient affiliated to a social security scheme or equivalent
What rules you out
- Study eye aphakic with missing posterior lens capsule
- Last session of focal laser treatment of the posterior pole of the study eye < 1 month
- Vitreo-macular traction syndrome associated with an epiretinal membrane in the study eye
- History of laser treatment in the macular grid of the study eye
- Ocular hypertension or open-angle glaucoma of the studied eye treated with at least one dual therapy.
- Patients with systemic pathology likely to interfere with the evolution of DME and treated with immunosuppressants, systemic corticoids, anti-aldosterone, systemic anti-VEGF, etc.
- Patients undergoing systemic treatment with a toxic effect on the retina or optic nerve: deferoxamine, chloroquine /hydroxychloroquine, tamoxifen and ethambutol; currently or in the 6 months prior to inclusion.
- Known hypersensitivity to the active substance or to one of the excipients or to anesthetic or hypotonizing eye drops.
- History of any pathology, metabolic disease, or any serious suspicion of disease on clinical or laboratory examination, which would contraindicate the use of the dexamethasone intraretinal implant, could affect the interpretation of study results or entail significant risks of complication for the subject.
- Active or suspected infectious conjunctivitis and/or adnexal infection
- Any ocular disease or condition of the study eye which, in the opinion of the investigator, may require intraocular surgery within 12 months
- History of focal laser located in the study eye less than 750 microns from the fovea (1/2 Papillary Diameter)
- Contralateral eye with visual acuity < 23 letters
- Pregnant or breast-feeding women
- Women of childbearing age, sexually active, unwilling to commit to the use of adequate and highly effective contraception during the study and up to 6 months after the last administration of study treatment: o Combined hormonal contraception (containing estrogen and progestin) for ovulation inhibition (oral, intravaginal or transdermal); o Hormonal contraception containing only a progestin to inhibit ovulation (oral, injectable or implantable); o Intrauterine device (IUD); o Intrauterine hormone delivery system (IUD); o Ovariectomy with hysterectomy, bilateral tubal occlusion or total hysterectomy for at least 6 weeks prior to inclusion, or vasectomy for at least 6 months prior to inclusion (for partners of an included patient); o Sexual abstinence. A woman will be considered to be of childbearing age from the time of her first menstrual period until the menopausal period, unless she is sterile or has had surgery such as oophorectomy with hysterectomy, bilateral tubal occlusion or total hysterectomy at least 6 weeks prior to inclusion. A post-menopausal state is defined as the absence of spontaneous menses (i.e., without other medical treatment such as hormonal contraception or hormone replacement therapy) for 12 months.
- Patient of legal age (Code de la Santé Publique)
- Patient currently participating in another interventional clinical trial (eye studied and/or eye not studied).
- Follow-up not possible for 24 months, at the investigator's discretion
- Ischaemic maculopathy (more than 2-fold increase in the surface area of the central avascular zone)
- Proliferative diabetic retinopathy (presence of pre-retinal neovessels) in the study eye
- Eye studied with an anterior chamber implant or intraocular implant with iridal or transcleral fixation or rupture of the posterior lens capsule
- Eye studied with an ARTISAN® type lens implant
- Active or suspected periocular or ocular infection on the side being studied, including but not limited to most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and mycoses.
- Cataract surgery on the eye studied < 3 months
- Last session of panretinal laser photocoagulation of the study eye < 1 month
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.