NCT03093701

TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.

Detailed description

Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated. Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.

Conditions

• Retinal Vein Occlusion
• Macula Edema

Interventions

Type	Name	Description
DRUG	TLC399 (ProDex)	2-vial system: TLC399-DSP and TLC399-Lipid

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2017-03-28
• Last updated: 2021-12-23
• Results posted: 2021-12-23

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study