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

NCT02303184 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-02-08

Study results available
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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).

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Interventions

DRUG

4 mg CLS-TA

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

DRUG

Sham

suprachoroidal sham procedure

DRUG

IVT aflibercept

2 mg intravitreal injection of aflibercept

Sponsors & Collaborators

  • Clearside Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Ciulla, MD · Clearside Biomedical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303184 on ClinicalTrials.gov