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

Diabetic Macular Edema Clinical Trial

— TYBEE  

Official title:

Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126786
• Other study ID #: CLS1004-201
• Status: Completed
• Phase: Phase 2
• Start date: July 11, 2017
• Est. completion date: April 17, 2018

Study information

• Verified date: April 2021
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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")

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• IVT aflibercept
IVT aflibercept [2 mg/0.05 mL]
• Sham SC
sham SC
• SC CLS-TA
CLS-TA [4 mg/100 µL] SC injection

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Texas Retina Associates-Arlington	Arlington	Texas
United States	Western Carolina Retinal Associates	Asheville	North Carolina
United States	Emory Eye Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	The Johns Hopkins Wilmer Eye Institute	Baltimore	Maryland
United States	Retina Vitreous Medical Group Clinical Research	Beverly Hills	California
United States	Texas Retina Associates	Dallas	Texas
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Retina and Vitrous Associates of Kentucky	Lexington	Kentucky
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Valley Retina Institute	McAllen	Texas
United States	Valley Retina Institute, P.A.	McAllen	Texas
United States	Oregon Retina Institute	Medford	Oregon
United States	MedEye Associates	Miami	Florida
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 Specialty Institute	Pensacola	Florida
United States	Retinal Consultants of Arizona and Retinal Research Institute	Phoenix	Arizona
United States	Retina Consultants San Diego	Poway	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Retina Associates of NJ	Teaneck	New Jersey
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Retina Centers, PC	Tucson	Arizona
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Best Corrected Visual Acuity Letter Score	Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.	Baseline, 6 months
Secondary	Mean Change From Baseline in Central Subfield Thickness	Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.	Baseline, 6 months