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

NCT02980874 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2021-04-14

Study results available
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Summary

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Interventions

DRUG

suprachoroidal CLS-TA

suprachoroidal injection of CLS-TA

DRUG

suprachoroidal 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 MBA · 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
2017-01-31
Primary Completion
2018-12-10
Completion
2018-12-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • Hungary
  • India
  • Israel
  • Italy
  • Philippines
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Taiwan
  • United Kingdom

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 NCT02980874 on ClinicalTrials.gov