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Dextenza in the Post-op Management of Vitreoretinal Surgeries

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later May 1, 2026 → Dec 1, 2027
See other at-risk trials from The Cleveland Clinic

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 1, 2026 to Dec 1, 2027v10
  2. Primary and study completion dates: Dec 1, 2025 to May 1, 2026v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Dec 1, 2023 to Dec 1, 2025v7 Show 4 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Study completion date: Jun 1, 2024 to Dec 1, 2025
    • Start date: Dec 1, 2020 to Jun 1, 2020
    • Site details revised
  5. Primary completion date: Dec 1, 2022 to Dec 1, 2023
    • Study completion date: Jun 1, 2023 to Jun 1, 2024
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Dec 1, 2021 to Dec 1, 2022
    • Study completion date: Jun 1, 2022 to Jun 1, 2023
    v5
  2. Primary completion date: Jun 1, 2021 to Dec 1, 2021v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Jun 1, 2020 to Dec 1, 2020
    • Site contact updated
    v3
  4. Secondary endpoints revised (7)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
Trial Details
NCT Number NCT04371445
Lead Sponsor The Cleveland Clinic
Collaborators: Ocular Therapeutix, Inc.
Conditions
(from sponsor)		 Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain, Post-Operative Inflammation
Related terms Postoperative Pain
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov