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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-10

Study Completion Date

2017-10-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TX Naïve Arm

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.

Group Type EXPERIMENTAL

IVT Aflibercept

Intervention Type DRUG

IVT aflibercept \[2 mg (50 µL)\]

SC CLS-TA

Intervention Type DRUG

\[4 mg (100 µL)\]

Previous TX Arm

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

Group Type EXPERIMENTAL

SC CLS-TA

Intervention Type DRUG

\[4 mg (100 µL)\]

Interventions

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IVT Aflibercept

IVT aflibercept \[2 mg (50 µL)\]

Intervention Type DRUG

SC CLS-TA

\[4 mg (100 µL)\]

Intervention Type DRUG

Other Intervention Names

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Aflibercept Triamcinolone Acetonide

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No