Clinical trial NCT02949024: Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetes mellitus
Diabetic retinopathy
Microneedle
Microinjection
Triamcinolone
Choroid
Choroid Injection
Aflibercept
Suprachoroidal
Triamcinolone acetonide
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
timeFrame: Over 6 months of follow-up
Secondary outcomes:
measure: Mean Change From Baseline in Intraocular Pressure
timeFrame: Baseline and 6 months
measure: Mean Change From Baseline in Central Subfield Thickness
timeFrame: Baseline and 6 months
measure: Best Corrected Visual Acuity
timeFrame: Baseline and 6 months
measure: CLS-TA Injections
timeFrame: 2 to 6 months following initial treatment with study drug
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Retina Vitreous Associates Medical Group Inc
state: California
city: The Woodlands
country: United States
facility: Retina Consultants of Houston, PA
state: Texas
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD MBA
role: STUDY_DIRECTOR
References: