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Diabetic Macular EdemaPhase 2LOADEXNCT04116398

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

A Phase 2 study testing Dexamethasone with 2 loading doses followed by PRN regimen. in people with Diabetic Macular Edema, run by Hospices Civils de Lyon at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Dexamethasone with 2 loading doses followed by PRN regimen.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
16 sitesFrance
Study dates
30 Nov 2020to 3 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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%
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • APHP - Hôpital Avicenne

    Bobigny, 93000

  • CHU Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000

  • Centre Rétine Gallien

    Bordeaux

  • Hôpital Intercommunal de Créteil

    Créteil, 94010

  • CHU Dijon

    Dijon, 21079

  • CHRU Lille - Hôpital Huriez

    Lille, 59037

  • Hôpital Edouard Herriot

    Lyon, 69003

  • Hospices Civils de Lyon - Hopital de la Croix Rousse

    Lyon, 69004

  • Centre Monticelli Paradis d'ophtalmologie

    Marseille, 13008

  • APHM - Hôpital Nord

    Marseille, 13015

  • Clinique Juge

    Marseille

  • APHP - Hôpital Lariboisière

    Paris, 75010

  • Centre Hospitalier National d'Ophtalmologie des XV XX

    Paris, 75012

  • CHU de Poitiers - La miletrie

    Poitiers, 86000

  • Clinique Mathilde

    Rouen

  • CHU Toulouse - Hôpital Pierre Paul Riquet

    Toulouse, 31059

Other trials in France

About this study

Official title: Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema

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.

Being tested
Dexamethasone with 2 loading doses followed by PRN regimen.
Keywords
dexamethasone,, loading dose,, diabetic macular edema, pseudophakic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone with 2 loading doses followed by PRN regimen.Drug

    • Loading dose with 2 systematic intravitreal injections (IVI) of ozurdex at the baseline and 12 weeks.Followed by a PRN regimen with strict retreatment criteria (already used and published in the Prediamex study, Bellocq,Kodjikian et al Ophthalmology Retina 2017)
    • Retreatment criteria: Reduction in VA ≥ 5 ETDRS Letters; and/or CSMT ≥ 275 microns by OCT-Cirrus® or ≥ 285 microns by OCT Spectralis®/Topcon; and/or increase of CSMT > 50 microns; and/or onset of recurrent retinal cysts; and/or residual edema considered by the practitioner to be clinically significant.
    • Minimal time limit between two IVI : 12 weeks
    • Visits: monthly during 1 year (to check efficacy and safety) and then for the 2nd-year only at Month18 (M18) and Month 24 (M24)
Study groups in NCT04116398
Study groupRoleWhat they receive
Ozurdex®, 700µg dexamethasone intravitreal injectionExperimentalIntravitreal injection of dexamethasone (Ozurdex®)
Receives: Drug: Dexamethasone with 2 loading doses followed by PRN regimen.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum BCVA (Best Corrected Visual Acuity) change (best improvement) from baseline (during one year of treatment)

    Best Corrected Visual Acuity (BCVA) is measured on the ETDRS scale at an initial distance of 4 meters.

    Measured: 52 weeks

Secondary outcomes (37)

  1. The time required to obtain the best BCVA

    average, standard deviation, median, minimum and maximum

    Measured: 52 weeks

  2. The number of injections required to obtain the best BCVA

    average, standard deviation, median, minimum and maximum

    Measured: 52 weeks

  3. the maximum best corrected visual acuity (BCVA) change (best improvement) measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale

    Best Corrected Visual Acuity (BCVA) is measured on the ETDRS scale at an initial distance of 4 meters.

    Measured: between the baseline and 1,5 years and between the baseline and 2 years

  4. values of Visual Acuity (VA) at each visit

    Measured: all visits during 2 years

  5. Area under the curve (AUC) of VA

    AUC calculated with the values of VA at each visit

    Measured: between the baseline and 52 weeks and between the baseline and 2 years

  6. Description of Visual acuity (VA)

    categorized change of VA (>=+15 ; +10 -> +15 ; +5 -> +10 ; -5 -> +5 (stable) ; -5 -> -10 ; -10 -> -15 ; > -15)

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  7. Number of IVI

    Measured: 1 year

  8. Number of IVI

    Measured: 2 years

  9. OCT parameters: Central Subfield Mean Thickness (CSMT)

    average, standard deviation, median, minimum and maximum

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  10. OCT parameters: Central Fovea Thickness

    average, standard deviation, median, minimum and maximum

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  11. OCT parameters : presence of interruptions of the ellipsoid line

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  12. OCT parameters : presence of continuous external limiting membrane

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the which obtained the BCVA

  13. OCT parameters : presence of disorganization of the internal retinal layers

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  14. OCT parameters : presence of intraretinal cysts

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  15. OCT parameters : presence of vitreomacular traction

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtain the BCVA

  16. OCT parameters : presence of epiretinal membrane

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  17. OCT parameters : presence of macular exudates

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  18. OCT parameters : persistance of foveolar depression

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 years, 2 years and the visit which obtained the BCVA

  19. OCT parameters : presence of intraretinal fluid

    Measured: at each visit

  20. Proportion of patients with macular edema resolution

    A macular edema resolution will be defined as absence of intraretinal fluid for at least 6 months after the last

    Measured: at 1 year

  21. Proportion of patients with macular edema resolution

    A macular edema resolution will be defined as absence of intraretinal fluid for at least 6 months after the last

    Measured: at 2 years

  22. Retinopathy parameters : presence of intraretinal or subretinal macular hemorrhage

    on stereoscopic 7-field color fundus photographs

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  23. Retinopathy parameters: presence of microaneurisms

    on stereoscopic 7-field color fundus photographs

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  24. Retinopathy parameters : presence of macular exudates

    on stereoscopic 7-field color fundus photographs

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  25. Severity evolution (improvement, no change, worsening) of diabetic retinopathy graded by 2 evaluators on stereoscopic 7-field color fundus photographs

    Using the Stadification Diabetic Retinopathy Severity Scale (DRSS), 5 levels: No apparent retinopathy, Mild Non Proliferative Diabetic Retinopathy (NPDR), Moderate NPDR,severe NDPR and Proliferative Diabetic Retinopathy (PDR)

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  26. Quantitative OCT-angiography analysis : the size of non-perfusion zones

    The mean (and standard deviation) the median (minimum-maximum) of the size of non-perfusion

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  27. Quantitative OCT-angiography analysis : the size of central avascular zones

    The mean (and standard deviation) the median (minimum-maximum) of the size of central avascular zones compared with baseline

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  28. Qualitative OCT-angiography analysis : presence of macular ischemia

    the number of macular ischemia

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  29. Qualitative OCT-angiography analysis : Evolution of macular ischemia compared to the baseline

    Types of evolution compared to baseline : appearance / disappearance / stability of the macular ischemia.

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  30. Qualitative OCT-angiography analysis : presence of preretineal neovessels

    the number of preretineal neovessels,

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  31. Qualitative OCT-angiography analysis : evolution of preretineal neovessels compared to the baseline

    Types of evolution : appearance / disappearance / stability.

    Measured: Baseline, 12 weeks, 24 weeks,36 weeks,52 weeks, 1.5 year and 2 years

  32. Biomicroscopy: the number and the percentage by categories of the condition of the implant

    conditions : clear, opacified , integrity, open, performed capsulotomy

    Measured: all visits during 2 years

  33. Biomicroscopy: presence of the state of the posterior capsule

    absence or presence of the posterior capsule

    Measured: all visits during 2 years

  34. Variation of the intraocular pressure

    Measured: all visits during 2 years

  35. proportion of patients using hypotonic eye treatment

    Measured: all visits during 2 years

  36. Number of adverse events

    All adverse events will be coded using the Meddra system organ class and cases of patients stopping or switching drugs will be described (causes, new drugs,..)

    Measured: all visits during 2 years

  37. Level of discomfort felt by the patient

    Discomfort felt by the patient measured by a visual analog scale (EVA between 0 and 10 (0 = no discomfort))

    Measured: all visits during 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2019
  2. Study start30 Nov 2020
  3. Primary completion28 Aug 2025
  4. Study completion3 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04116398
Sponsor's protocol ID
69HCL19_0588
Other IDs
2019-003092-18, 2024-514362-39-00, 2019
Acronym
LOADEX
Status last verified
Sep 2026
First submitted
16 Sep 2019
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone with 2 loading doses followed by PRN regimen. in people with Diabetic Macular Edema, run by Hospices Civils de Lyon at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum BCVA (Best Corrected Visual Acuity) change (best improvement) from baseline (during one year of treatment) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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