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

NCT ID: NCT03126786

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2018-04-17

Brief 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.

Detailed Description

This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.

The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA

Group Type: ACTIVE_COMPARATOR

IVT aflibercept

Intervention Type: DRUG

IVT aflibercept \[2 mg/0.05 mL\]

SC CLS-TA

Intervention Type: DRUG

CLS-TA \[4 mg/100 μL\] SC injection

Control

Treatment will consist of IVT aflibercept injection followed by a sham SC procedure

Group Type: SHAM_COMPARATOR

IVT aflibercept

Intervention Type: DRUG

IVT aflibercept \[2 mg/0.05 mL\]

Sham SC

Intervention Type: DRUG

sham SC

Interventions

IVT aflibercept

IVT aflibercept \[2 mg/0.05 mL\]

Intervention Type: DRUG

Sham SC

sham SC

Intervention Type: DRUG

SC CLS-TA

CLS-TA \[4 mg/100 μL\] SC injection

Intervention Type: DRUG

Other Intervention Names

Eylea; suprachoroidal sham; Triamcinolone Acetonide

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of type 1 or type 2 DM
• DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye
• ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
• Naïve to local pharmacologic treatment for DME in the study eye

Exclusion Criteria

• IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication
• Any previous treatment in the study eye with an ocular corticosteroid implant
• Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
• History of glaucoma or optic nerve head change consistent with glaucoma damage
• History of glaucoma surgery
• History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clearside Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Ciulla, MD

Role: STUDY_DIRECTOR

Clearside Biomedical

Locations

Retinal Consultants of Arizona and Retinal Research Institute

Phoenix, Arizona, United States

Retina Centers, PC

Tucson, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retina Vitreous Medical Group Clinical Research

Beverly Hills, California, United States

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, United States

Retina Institute of California

Palm Desert, California, United States

Retina Consultants San Diego

Poway, California, United States

MedEye Associates

Miami, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Emory Eye Center

Augusta, Georgia, United States

Marietta Eye Clinic

Marietta, Georgia, United States

Midwest Eye Institute

Indianapolis, Indiana, United States

Retina and Vitrous Associates of Kentucky

Lexington, Kentucky, United States

The Johns Hopkins Wilmer Eye Institute

Baltimore, Maryland, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Retina Associates of NJ

Teaneck, New Jersey, United States

Western Carolina Retinal Associates

Asheville, North Carolina, United States

Oregon Retina Institute

Medford, Oregon, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Texas Retina Associates-Arlington

Arlington, Texas, United States

Austin Retina Associates

Austin, Texas, United States

Texas Retina Associates

Dallas, Texas, United States

Valley Retina Institute, P.A.

McAllen, Texas, United States

Valley Retina Institute

McAllen, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Retina Consultants of Houston

The Woodlands, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLS1004-201

Identifier Type: -

Identifier Source: org_study_id