Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

Part of paid clinical trials in Mountain View, California.

Sponsor
Clearside Biomedical, Inc.
Study ID
NCT02949024
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • IVT Aflibercept — DRUG
    IVT aflibercept \[2 mg (50 µL)\]
  • SC CLS-TA — DRUG
    \[4 mg (100 µL)\]

Study Details

This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.

Key Dates

Start date
Nov 10, 2016
Status verified
Apr 2021
Primary completion
Oct 17, 2017
Completion
Oct 17, 2017

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TX Naïve Arm
    Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
  • Experimental: Previous TX Arm
    Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events [ Time Frame: Over 6 months of follow-up ]

Locations (2)

FacilityCityStateZIPSite coordinators
Retina Vitreous Associates Medical Group IncMountain ViewCalifornia94040-
Retina Consultants of Houston, PAThe WoodlandsTexas77384-

Find similar trials in Mountain View, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Vitreous Associates Medical Group Inc· Mountain View, CARetina Consultants of Houston, PA· The Woodlands, TX

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