A Phase I/II Trial of TLC399 (ProDex) in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO): An Open-label, Sequential Dose Escalation Phase I Part to Determine Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) Followed by a Single-masked, Randomized Part to Evaluate Efficacy and Tolerability

Trial Profile

A Phase I/II Trial of TLC399 (ProDex) in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO): An Open-label, Sequential Dose Escalation Phase I Part to Determine Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) Followed by a Single-masked, Randomized Part to Evaluate Efficacy and Tolerability

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 Apr 2016

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Branch retinal vein occlusion; Central retinal vein occlusion; Retinal oedema
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Taiwan Liposome Company
  • Most Recent Events

    • 11 Apr 2016 Planned End Date changed from 1 Mar 2016 to 1 Dec 2018.
    • 11 Apr 2016 Planned primary completion date changed from 1 Mar 2016 to 1 Dec 2018.
    • 02 Jun 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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