At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 14 enrolled
Drug / intervention
TLC399drug
Likely dose
TLC399 0.24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of TLC399 (ProDex) in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
In Brief
A Phase 2 clinical trial evaluating TLC399 for Central Retinal Vein Occlusion With Macular Edema and Branch Retinal Vein Occlusion With Macular Edema. Completed, enrolled 14 participants across 6 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Retinal Vein Occlusion With Macular Edema, Branch Retinal Vein Occlusion With Macular Edema
CountriesTaiwan
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartNov 2014
Primary CompletionJul 2020
TodayJul 2026
First PostedDec 10, 2013
Enrollment StartNov 1, 2014
Primary CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.6 years ago
Interventions
TLC399drug
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.