Clinical trial NCT03126786: Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetes Mellitus
Diabetic Retinopathy
Microneedle
Mircoinjection
Triamcinolone
Choroid
Choroid Injection
Aflibercept
Suprachoroidal
Triamcinolone acetonide
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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")

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Mean Change From Baseline in Central Subfield Thickness
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona and Retinal Research Institute
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, PC
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Medical Group Clinical Research
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Emory Eye Center
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Retina and Vitrous Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins Wilmer Eye Institute
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Asheville
country: United States
facility: Western Carolina Retinal Associates
state: North Carolina
city: Medford
country: United States
facility: Oregon Retina Institute
state: Oregon
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates-Arlington
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Clearside Biomedical
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References: