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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Clearside Biomedical, Inc.
Study ID
NCT03126786
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jul 11, 2017
Status verified
Apr 2021
Primary completion
Apr 17, 2018
Completion
Apr 17, 2018

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
  • Sham Comparator: Control
    Treatment will consist of IVT aflibercept injection followed by a sham SC procedure

Primary Outcome Measure

Mean Change From Baseline in Best Corrected Visual Acuity Letter Score [ Time Frame: Baseline, 6 months ]

Locations (29)

FacilityCityStateZIPSite coordinators
Retinal Consultants of Arizona and Retinal Research InstitutePhoenixArizona85014-2709-
Retina Centers, PCTucsonArizona85704-
California Retina ConsultantsBakersfieldCalifornia93309-
Retina Vitreous Medical Group Clinical ResearchBeverly HillsCalifornia90211-1841-
Northern California Retina Vitreous Associates Medical Group, Inc.Mountain ViewCalifornia94040-
Retina Institute of CaliforniaPalm DesertCalifornia92260-
Retina Consultants San DiegoPowayCalifornia92064-2526-
MedEye AssociatesMiamiFlorida33143-5188-
Retina Specialty InstitutePensacolaFlorida32503-
Sarasota Retina InstituteSarasotaFlorida34239-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Emory Eye CenterAugustaGeorgia30909-6440-
Marietta Eye ClinicMariettaGeorgia30060-
Midwest Eye InstituteIndianapolisIndiana46290-
Retina and Vitrous Associates of KentuckyLexingtonKentucky40509-
The Johns Hopkins Wilmer Eye InstituteBaltimoreMaryland21287-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-5940-
Retina Associates of NJTeaneckNew Jersey07666-
Western Carolina Retinal AssociatesAshevilleNorth Carolina28803-
Oregon Retina InstituteMedfordOregon97504-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-7374-
Retina Research Institute of TexasAbileneTexas79606-1224-
Texas Retina Associates-ArlingtonArlingtonTexas76012-2505-
Austin Retina AssociatesAustinTexas78705-
Texas Retina AssociatesDallasTexas75231-
Valley Retina InstituteMcAllenTexas78503-
Valley Retina Institute, P.A.McAllenTexas78503-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-1502-
Retina Consultants of HoustonThe WoodlandsTexas77384-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retinal Consultants of Arizona and Retinal Research Institute· Phoenix, AZRetina Centers, PC· Tucson, AZCalifornia Retina Consultants· Bakersfield, CARetina Vitreous Medical Group Clinical Research· Beverly Hills, CANorthern California Retina Vitreous Associates Medical Group, Inc.· Mountain View, CARetina Institute of California· Palm Desert, CA

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