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

Phase 1

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: IVT Aflibercept; Drug: SC CLS-TA

• Registration Number: NCT02949024
• Lead Sponsor: Clearside Biomedical, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Study Start: 2016-11-10
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Disposition First Submitted: 2018-05-07
• Disposition First Submitted QC: 2018-05-07
• Disposition First Posted: 2018-05-09
• Results First Submitted: 2021-03-23
• Results First Submitted QC: 2021-03-23
• Status Verified: 2021-04
• Results First Posted: 2021-04-19
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TX Naïve Arm	IVT Aflibercept	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.
TX Naïve Arm	SC CLS-TA	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.
Previous TX Arm	SC CLS-TA	Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events	Over 6 months of follow-up	Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up

Secondary Outcome Measures

Name	Time	Method
CLS-TA Injections	2 to 6 months following initial treatment with study drug	After the initial treatment with CLS-TA, with or without intravitreal aflibercept, at Baseline, retreatment with CLS-TA was allowed in either treatment group from Month 2 through Month 6 if pre-defined retreatment criteria were met. Number of patients receiving 0, 1, 2, 3, 4 or 5 retreatments with CLS-TA.
Mean Change From Baseline in Intraocular Pressure	Baseline and 6 months	Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry
Mean Change From Baseline in Central Subfield Thickness	Baseline and 6 months	Baseline and change from baseline at 6 months in central subfield thickness. Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Best Corrected Visual Acuity	Baseline and 6 months	Baseline and Change from baseline at 6 months in best corrected visual acuity before and after treatment Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured as the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.

Trial Locations

Locations (2)

Retina Vitreous Associates Medical Group Inc; 🇺🇸 Mountain View, California, United States

Retina Consultants of Houston, PA; 🇺🇸 The Woodlands, Texas, United States