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Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for DME

2016-10-26 05:53:21 | BioPortfolio

Summary

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

The purpose of this trial is to evaluate the safety and preliminary efficacy of suprachoroidal (SC) CLS-TA in subjects with DME associated with diabetes mellitus.

CLS-TA, triamcinolone acetonide injectable suspension, is a sterile, preservative-free, aqueous suspension formulated for administration into the eye. The drug product is terminally sterilized and is intended for single use. CLS-TA is supplied as a 40 mg/mL sterile suspension in a 2 mL/13 mm TopLyo single use vial with a rubber stopper and an aluminum seal.

This is a Phase 1/2, multicenter, open-label study in subjects with DME associated with diabetes mellitus. Subjects will be screened and if eligible, will be assigned to a study arm at the Baseline Visit. Following the Baseline Visit, subjects will participate in six monthly follow-up visits for safety and efficacy assessments and to determine whether additional therapy is needed based upon established criteria.

Subjects will be assigned to one of two treatment arms in the study based upon prior treatment for DME in the study eye. Those subjects who have never received treatment in the study eye for DME or whose DME treatment in the study was more than 1 year prior to the screening date, at the PI's discretion, will be enrolled into the TX Naive study arm. Those subjects who have received treatment for DME in the study eye within the last 12 months, will be enrolled into the Previous TX study arm.

Treatment in the TX Naive arm will consist of one unilateral injections of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.

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

Approximately 20 subjects will be assigned in a 1:1 ratio where approximately 10 subjects will be enrolled into the TX Naive arm and approximately 10 subjects will be enrolled into the Previous TX arm.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetic Macular Edema

Intervention

SC CLS-TA, IVT Aflibercept

Status

Not yet recruiting

Source

Greater Houston Retina Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-26T05:53:21-0400

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Medical and Biotech [MESH] Definitions

Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)

Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.

A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.

Vision considered to be inferior to normal vision as represented by accepted standards of acuity, field of vision, or motility. Low vision generally refers to visual disorders that are caused by diseases that cannot be corrected by refraction (e.g., MACULAR DEGENERATION; RETINITIS PIGMENTOSA; DIABETIC RETINOPATHY, etc.).

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