Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for DME — HULK  

Diabetic Macular Edema Clinical Trial

Official title: 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 (the HULK Trial)

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The purpose of this trial is to evaluate the safety and preliminary efficacy of suprachoroidal (SC) CLS-TA in subjects with DME associated with diabetes mellitus.

CLS-TA, triamcinolone acetonide injectable suspension, is a sterile, preservative-free, aqueous suspension formulated for administration into the eye. The drug product is terminally sterilized and is intended for single use. CLS-TA is supplied as a 40 mg/mL sterile suspension in a 2 mL/13 mm TopLyo single use vial with a rubber stopper and an aluminum seal.

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

Subjects will be assigned to one of two treatment arms in the study based upon prior treatment for DME in the study eye. Those subjects who have never received treatment in the study eye for DME or whose DME treatment in the study was more than 1 year prior to the screening date, at the PI's discretion, will be enrolled into the TX Naive study arm. Those subjects who have received treatment for DME in the study eye within the last 12 months, will be enrolled into the Previous TX study arm.

Treatment in the TX Naive arm will consist of one unilateral injections of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.

Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.

Approximately 20 subjects will be assigned in a 1:1 ratio where approximately 10 subjects will be enrolled into the TX Naive arm and approximately 10 subjects will be enrolled into the Previous TX arm. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

• NCT number: NCT02944240
• Study type: Interventional
• Source: Greater Houston Retina Research
• Contact: Cassie Cone, BA
• Phone: 713-524-3434
• Email: cassandra.cone@houstonretina.com
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2016