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

Diabetic Macular Edema Clinical Trial

— HULK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949024
• Other study ID #: CLS1004-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 10, 2016
• Est. completion date: October 17, 2017

Study information

• Verified date: April 2021
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02944240

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• IVT Aflibercept
IVT aflibercept [2 mg (50 µL)]
• SC CLS-TA
[4 mg (100 µL)]

Locations

Country	Name	City	State
United States	Retina Vitreous Associates Medical Group Inc	Mountain View	California
United States	Retina Consultants of Houston, PA	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events	Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up	Over 6 months of follow-up
Secondary	Mean Change From Baseline in Intraocular Pressure	Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry	Baseline and 6 months
Secondary	Mean Change From Baseline in Central Subfield Thickness	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.	Baseline and 6 months
Secondary	Best Corrected Visual Acuity	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.	Baseline and 6 months
Secondary	CLS-TA Injections	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.	2 to 6 months following initial treatment with study drug