CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
4 mg CLS-TA +2 moredrug
Likely dose
4 mg CLS-TAfrom 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.

Search/NCT02303184
NCT02303184Phase 2Completed
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TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion

Clearside Biomedical, Inc.·interventional·Posted Nov 27, 2014·Updated Feb 8, 2021

In Brief

A Phase 2 clinical trial evaluating 4 mg CLS-TA, Sham, and 1 other intervention for Macular Edema and Retinal Vein Occlusion. Completed, enrolled 46 participants across 14 sites.

Detailed Summary

A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema, Retinal Vein Occlusion
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 27, 2014
Enrollment StartJan 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.6 years ago

Interventions

4 mg CLS-TAdrug

40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Shamdrug

suprachoroidal sham procedure

IVT afliberceptdrug

2 mg intravitreal injection of aflibercept