Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Clearside Biomedical, Inc.
Study ID
NCT02303184
Phase
PHASE2
Status
Completed

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

  • 4 mg CLS-TA — DRUG
    40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
  • Sham — DRUG
    suprachoroidal sham procedure
  • IVT aflibercept — DRUG
    2 mg intravitreal injection of aflibercept

Study Details

A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Key Dates

Start date
Jan 31, 2015
Status verified
Jan 2021
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

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

Arms

  • Experimental: 4 mg CLS-TA + IVT aflibercept
    Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
  • Active Comparator: sham + IVT aflibercept
    Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

Primary Outcome Measure

Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm [ Time Frame: 3 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
-PhoenixArizona85014-
-Beverly HillsCalifornia90211-
-San DiegoCalifornia92037-
-Boynton BeachFlorida33426-
-AtlantaGeorgia30322-
-BaltimoreMaryland21287-
-St LouisMissouri63128-
-Winston-SalemNorth Carolina27157-
-Rapid CitySouth Dakota57701-
-AbileneTexas79606-
-HoustonTexas77030-
-McAllenTexas78503-
-San AntonioTexas78251-
-The WoodlandsTexas77384-

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