Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

Study Identifier
P23-380
CT.gov Identifier
NCT05978622
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Macular Edema
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant diagnosed with DME in the study eye * Study eye has received at least 3 and no more than 9 anti-VEGF injections in the 12 months prior to DEX-I initiation * Study eye newly prescribed DEX-I. The prescribing decision lies with the physician and reflects their standard practice * Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye
    Exclusion Criteria:
    * Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract) * History of ocular surgery within 60 days of Baseline in the study eye * History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline * Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality * Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study eye * Active ocular inflammation in either eye * Study eyes that are aphakic with Posterior Capsule Rent (PCR), Anterior Chamber Intraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history of complicated cataract surgery with PCR * Prior use of intravitreal corticosteroids in the study eye * Patients with contraindications to DEX-I

    Protocol Summary

    The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting.

    Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally.

    Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study.

    No additional burden for participants in this trial is expected.

    Study Locations

    Location
    Status
    Location
    Uza /Id# 255831
    Edegem, Antwerpen, Belgium, 2650
    Status
    Not applicable
    Location
    CHU Saint Pierre /ID# 257650
    Brussels, Brussels Capital, Belgium, 1000
    Status
    Not applicable
    Location
    Universitair Ziekenhuis Brussel /ID# 255324
    Jette, Brussels Capital, Belgium, 1090
    Status
    Not applicable
    Location
    Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934
    Genk, Limburg, Belgium, 3600
    Status
    Not applicable
    Location
    Vitaz /Id# 265553
    Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    Status
    Not applicable
    Location
    CHR de la Citadelle /ID# 257254
    Liège, Belgium, 4000
    Status
    Not applicable
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