NCT02006147

Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO

Phase I/II Trial of TLC399 (ProDex) in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To determine whether TLC399 (ProDex) provides an ideal, safe, long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of macular edema due to retinal vein occlusion (RVO).

Detailed description

\<Part 1\> An open-label, sequential dose escalation part to determine the DLT of TLC399 (ProDex) in patients with macular edema due to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). The safety results should be evaluated by Safety Monitor Committee regularly every 6 months and after last patient of each cohort completes DLT observation period. The SMC would advise or give permission for further dose escalation, de-escalation, or any study design adjustment. After the study drug administration, these patients will continue to be evaluated for efficacy and safety outcomes up to a period of 12 months unless the patient is withdrawn or discontinues the study. * Group R1: 0.24 mg DSP with 100 mM PL (20 µL) * Group 1: 0.36 mg DSP with 100 mM PL (30 µL) * Group 2: 0.6 mg DSP with 100 mM PL (50 µL) * Group 3: 0.6 mg DSP with 50 mM PL (50 µL) \<Part 2\> An open-label, single-arm design to investigate the use of TLC399 (ProDex) in patients with macular edema due to CRVO or BRVO in one dose level selected from Part 1. The enrollment of subjects for analysis will include approximately 20 patients in total, inclusive of Part 1 and Part 2 for the selected dose group. The safety and efficacy outcomes will be assessed for up to 12 months.

Conditions

• Central Retinal Vein Occlusion With Macular Edema
• Branch Retinal Vein Occlusion With Macular Edema

Interventions

Type	Name	Description
DRUG	TLC399	Dose-escalation Study from 100 mM PL (20 µL) with 0.24 mg DSP to 100 mM PL (20 µL) with0.36 mg DSP to 100 mM PL (20 µL) with 0.6 mg DSP to 50 mM PL (10 µL) with 0.6 mg DSP.

Timeline

• Start date: 2014-11-01
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2013-12-10
• Last updated: 2021-12-23
• Results posted: 2021-12-23

Locations

6 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study