Mean Visual Acuity Changes Following Five Injections of Aflibercept

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Sep 2025 → Sep 2027
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Record History

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  1. Primary completion pushed from Sep 2025 to Sep 2027
    • Study completion pushed from Dec 2025 to Dec 2027
    • Eligibility criteria expanded, about 15 words
    • Site details revised
  2. Primary completion date: Sep 2024 to Sep 2025
    • Study completion date: Dec 2024 to Dec 2025
    v6
  3. Primary completion date: Dec 2023 to Sep 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 2024 to Dec 2024
    • Site details revised
    v5
  4. Primary completion date: Dec 2018 to Dec 2023
    • Study completion date: Jul 2019 to Jan 2024
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study completion date: Mar 2019 to Jul 2019
    • Start date changed from estimate of Apr 2018 to May 1, 2018
    v3
  6. Primary completion date: Aug 2016 to Dec 2018v2 Show 5 more changesShow less
    • Start date: Mar 2016 to Apr 2018
    • Study completion date: Mar 2019
    • Interventions: aflibercept (Drug) to Aflibercept Injection [Eylea] (Drug)
    • Eligibility criteria shortened, about 28 words
    • Study description expanded, about 680 words
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even though significant research has been done to clarify the pathogenesis of DME, a clear causal pathway of the complication is of yet undetermined. However, there is some consensus among researchers that a cascade of inflammatory markers plays an important role in the disease process. The study hopes to better delineate the role these inflammatory markers play by investigating whether basal levels predict response or lack thereof to Aflibercept.
Trial Details
NCT Number NCT02645266
Lead Sponsor McMaster University
Conditions
(from sponsor)		 Diabetic Macular Edema
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov