NCT03126786

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Macular Edema

Interventions

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

Timeline

• Start date: 2017-07-11
• Primary completion: 2018-04-17
• Completion: 2018-04-17
• First posted: 2017-04-24
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study