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Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

NCT03126786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-05-13

Study results available
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Summary

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

Conditions

Interventions

DRUG

IVT aflibercept

IVT aflibercept \[2 mg/0.05 mL\]

DRUG

Sham SC

sham SC

DRUG

SC CLS-TA

CLS-TA \[4 mg/100 μL\] SC injection

Sponsors & Collaborators

  • Clearside Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Ciulla, MD · Clearside Biomedical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2018-04-17
Completion
2018-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03126786 on ClinicalTrials.gov