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Completed

NCT Number: NCT02303184

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

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).

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Key information

Conditions

Macular Edema Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix, Arizona, United States

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About this study

A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of macular edema following RVO
  • History of ME ≤ 12 months
  • 20-70 letters inclusive BCVA using ETDRS

Exclusion criteria

  • has had an IVT injection of anti-VEGF for RVO in the study eye
  • has had a corticosteroid injection in the past 3 months in the study eye
  • any uncontrolled ophthalmic condition in the study eye other than RVO

Treatment and study plan

4 mg CLS-TA

Drug

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

sham

Drug

suprachoroidal sham procedure

Other names: suprachoroidal sham

IVT aflibercept

Drug

2 mg intravitreal injection of aflibercept

Other names: Eylea

Primary outcomes

  1. Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study title

TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion

Acronym: TANZANITE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2014
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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