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
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
- 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.