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

Clearside Biomedical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Drug: SC CLS-TA; Drug: IVT Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949024

CLS1004-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
• DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye
• ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye

Exclusion criteria

• Evidence of DME due to any other cause other than diabetes mellitus in the study eye
• PRP or focal laser photocoagulation in the study eye within 90 days of screening
• Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
• History of any previous ophthalmic surgeries in the study eye within 90 days of screening
• High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
• Any previous treatment in the study eye with ILUVIEN implant
• Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion
• Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)
• Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

TX Naïve Arm

Experimental group

Description:

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.

Treatment:

Drug: IVT Aflibercept

Drug: SC CLS-TA

Previous TX Arm

Experimental group

Description:

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

Treatment:

Drug: SC CLS-TA