A Study to Assess the Use of Artificial Intellignce to Predict Eye Treatment Changes in Adult Participants With Diabetic Macular Edema

Study Identifier
H25-796
CT.gov Identifier
NCT07604545
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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:
    * Previously untreated Diabetic macular edema (DME) Participants. * Baseline macular edema ≥350 microns confirmed on Spectralis Standard deviation (SD)-Optical coherence tomography (OCT) or equivalent. * Baseline Best corrected visual acuity (BCVA) between 23 and 78 Early treatment diabetic retinopathy study (ETDRS) letters (between 20/32 and 20/230 Snellen).
    Exclusion Criteria:
    * History of eyes with previous intravitreal or laser treatment for DME. * History of eyes with previous intraocular or periocular corticosteroid for DME. * History eyes with other macular disease, causing visual reduction or disturbance.

    Protocol Summary

    This study is to assess the use of Artificial intellignce (AI) to predict eye treatment changes in adult participants with diabetic macular edema (DME).

    Study Locations

    No locations found.