Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in DME Patients Treated With Aflibercept (FORESIGHT)

Sponsor
Hyewon Chung
Study ID
NCT03780361
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 17, 2019
Status verified
May 2024
Primary completion
Jan 1, 2023
Completion
Feb 1, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Aflibercept injection group
    drug: Eylea (aflibercept) (11.12mg/0.278ml) dose: 2mg (0.05ml) usage: With topical anesthesia and intravitreal injection of aflibercpt in aseptic condition. frequency and duration: monthly intravitreal aflibercept injections.

Primary Outcome Measure

Change in the level of sCD14 in the aqueous humor [ Time Frame: From baseline to week 20 ]

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