Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in DME Patient… (NCT03780361) | Clinical Trial Compass
CompletedPhase 4
Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in DME Patients Treated With Aflibercept (FORESIGHT)
South Korea23 participantsStarted 2019-05-17
Plain-language summary
This study evaluates the effect of aflibercept on the change of cytokines incluing sCD14, MCP-1, IL-6, and ICAM-1 in the aqueous humor of DME patients. Additionally, changes of visual acuity (ETDRS), optical coherence tomography parameters including hyperreflective foci and thickness of macula are also investigated.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Adults ≥ 19 years with type 1 or 2 diabetes mellitus.
✓. Patients with DME secondary to diabetes mellitus involving the center of the macula (defined as the OCT center subfield) in the study eye.
✓. Decrease in vision determined to be primarily the result of DME in the study eye.
✓. BCVA ETDRS letter score of 80 to 24 (20/25 to 20/320) in the study eye.
✓. Retinal thickness ≥ 300 µm as assessed by OCT in the study eye.
✓. Willing and able to comply with clinic visits and study-related procedures.
Exclusion criteria
✕. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
✕. History of vitreoretinal surgery in the study eye.
✕. Previous treatment with intraocular anti-angiogenic drugs (bevacizumab, ranibizumab etc.) or laser photocoagulation in the study eye within 90 days.
✕. Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1.
✕. Invasive intraocular surgery incluing cataract surgery within 90 days of day 1.
✕. Yttrium-aluminium-garnet capsulotomy in the study eye within 30 days before day 1.