NCT02949024

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

Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 1/2, multicenter, open-label study in subject with DME associated with diabetes mellitus. Subjects will be screened and if eligible, will be assigned to study arm at the Baseline Visit (Visit 1, Day 0). Following the Baseline Visit, subjects will participate in six monthly follow-up visits (Visit 2-7; Weeks 4-24) for safety and efficacy assessments and to determine whether additional therapy is needed based upon pre-defined criteria.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	IVT Aflibercept	IVT aflibercept \[2 mg (50 µL)\]
DRUG	SC CLS-TA	\[4 mg (100 µL)\]

Timeline

• Start date: 2016-11-10
• Primary completion: 2017-10-17
• Completion: 2017-10-17
• First posted: 2016-10-31
• Last updated: 2021-05-13
• Results posted: 2021-04-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study