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Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

NCT03203447 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2021-04-23

Study results available
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Summary

This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Interventions

DRUG

suprachoroidal CLS-TA

suprachoroidal injection of CLS-TA

DRUG

suprachoroidal sham

sham suprachoroidal procedure

DRUG

Lucentis or Avastin

IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Sponsors & Collaborators

  • Clearside Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Ciulla, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2018-12-18
Completion
2018-12-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Hungary
  • India
  • New Zealand

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 NCT03203447 on ClinicalTrials.gov