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

Study acronym: LOADEX
StatusCompleted
PhasePhase 2
Started2020-11-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
Study Status v15
Trial completed
Primary completion confirmed: August 2025 (last estimated December 2025)
Primary completion dateestimated 2025-12→confirmed 2025-08-28
Completion dateestimated 2026-12→confirmed 2026-09-03
2025-11-18
Study Status v14
Re-verified, no change to tracked fields
2025-01-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 100→confirmed 53
Study sites25→16
2024-08-05
Study Identification, Study Status, Contacts/Locations v12
Study sites24→25
2024-07-22
Study Status, Contacts/Locations v11
Study sitesdetails revised at 2 of 24 sites
Show 10 earlier versions
2024-05-28
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 24 sites
2024-05-23
Study Status, Eligibility, Contacts/Locations v9
Eligibility criteriarevised
[...] history of steroids or anti-VEGF) Pseudophakic for at least 63 months HBA1c < 10% Blood pressure < 160/95 Patient who give [...]
Study sitesdetails revised at 1 of 24 sites
2024-04-16
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v8
Study sites20→24
Eligibility criteria+7 characters
[...] ral Subfield Thickness (CST) ≥ 285 μm measured on Spectralis/topcon or ≥ 275 μm, as measured on Cirrus, at screening and VA bet [...]
2023-03-27
Study Status, Study Description, Arms and Interventions v7
Primary completion date2023-12→2025-12
Completion date2024-12→2026-12
2022-02-25
Study Status, Outcome Measures, Eligibility v6
Primary completion date2022-12→2023-12
Completion date2023-12→2024-12
Eligibility criteria-2 characters
[...] measured by SD-OCT, with Central Subfield Thickness (CST) ≥ 310285 μm measured on Spectralis or ≥ 300275 μm, as measured on Cirrus, at screening and VA between 20/3 [...] ns and mycoses At inclusion, delay after cataract surgery < 63 months in the study eye Delay after last session of panretineal Photocoagulation laser < 31 monthsmonth in the study eye Delay after last focal laser session of the posterior pole < 31 monthsmonth in the study eye Vitreomacular traction syndrome, associate [...]
Secondary endpoints35 to 37 entries
Qualitative OCT-angiography analysis : presence of preretineal neovessels Qualitative OCT-angiography analysis : evolution of preretineal neovessels compared to the baseline
2021-04-08
Study Status, Outcome Measures, Eligibility, Contacts/Locations v5
Study sites19→20
Eligibility criteria-152 characters
[...] capsule. Study eye with implant anterior chamber of the eye, or intraocular implant with iris fixated or transsclerally and andor ruptured posterior lens capsule. Study eye with lens implan [...] visual acuity < 23 letters Pregnant and breastfeeding woman Sexually active male or femaleFemale of reproductive age, sexually active, who does not want to commit to using adequate and highly ef [...] ysterectomy for at least 6 weeks before inclusion (for women, included or partners of a patient included) or vasectomy for at least 6 months before inclusion (for men , included or partners of a patient included); Sy [...] [...]
Secondary endpoints37 to 35 entries
OCT parameters : presencepersistance of foveolar depression Qualitative OCT-angiography analysis : presence of preretineal neovessels Qualitative OCT-angiography analysis : evolution of preretineal neovessels compared to the baseline
2020-12-15
Study Status, Contacts/Locations v4
Study sites1→19
2020-12-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-03→2022-12
Completion date2023-03→2023-12
Start dateestimated 2020-02→confirmed 2020-11-30
Study sitesdetails revised at 1 of 1 site
2020-02-10
Study Status, Outcome Measures v2
Secondary endpointsdetails revised at 1 of 37 entries
2020-02-05
Study Status, Outcome Measures, Eligibility v1
Primary completion date2022-02→2022-03
Completion date2023-02→2023-03
Start date2020-01→2020-02
Eligibility criteria+1,395 characters
[...] ons 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 Hyperten [...] visual acuity < 23 letters Pregnant and breastfeeding woman ManSexually active male or womanfemale of child-bearingreproductive 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 proges [...] [...]
Secondary endpoints36 to 37 entries
Level of discomfort felt by the patient
2019-10-03
Original filing
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.
Trial Details
NCT Number NCT04116398
Lead Sponsor Hospices Civils de Lyon
Conditions Diabetic Macular Edema
Enrollment 53 participants
Start Date 2020-11-30
Primary Completion 2025-08-28 (estimated)
Study Completion 2026-09-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-10