Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Interventions
- Registration Number
- NCT03126786
- Lead Sponsor
- Clearside Biomedical, Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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")
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Sham SC Treatment will consist of IVT aflibercept injection followed by a sham SC procedure Control IVT aflibercept Treatment will consist of IVT aflibercept injection followed by a sham SC procedure Active SC CLS-TA Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA Active IVT aflibercept Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Best Corrected Visual Acuity Letter Score Baseline, 6 months 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Central Subfield Thickness Baseline, 6 months 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.
Trial Locations
- Locations (29)
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Texas Retina Associates-Arlington
🇺🇸Arlington, Texas, United States
Retina Centers, PC
🇺🇸Tucson, Arizona, United States
California Retina Consultants
🇺🇸Bakersfield, California, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Institute of California
🇺🇸Palm Desert, California, United States
Emory Eye Center
🇺🇸Augusta, Georgia, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
The Johns Hopkins Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Retina and Vitrous Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Oregon Retina Institute
🇺🇸Medford, Oregon, United States
Retina Associates of NJ
🇺🇸Teaneck, New Jersey, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retinal Consultants of Arizona and Retinal Research Institute
🇺🇸Phoenix, Arizona, United States
MedEye Associates
🇺🇸Miami, Florida, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Retina Vitreous Medical Group Clinical Research
🇺🇸Beverly Hills, California, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
🇺🇸Mountain View, California, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States