A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema

CLKA651X2202

The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),

2019-05-24

2022-06-17

2022-08-31

Completed

Early phase I

91

Inclusion Criteria * Written informed consent must be obtained before any assessment is performed. * Male and female patients age 18 to 85 years of age inclusive at screening * Presence of type I or type II diabetes mellitus * The Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening * Presence of Diabetic macular edema (DME) in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥ 320 µm in the central subfield, as assessed on Spectral domain optical coherence tomography (SD-OCT) and confirmed by the central reading center at screening * Sufficiently clear ocular media and adequate pupil dilation in the study eye to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins at screening Exclusion criteria * Patient with history of intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye \<90 days from baseline * Patient with history of intraocular corticosteroids including dexamethasone intravitreal implants during the 6 month period prior to baseline. Any prior use of fluocinolone acetonide intravitreal implant (Iluvien) is prohibited regardless of timing * Laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline. * High risk proliferative diabetic retinopathy * Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C ≥ 12% at screening. * Any progressive disease of the retina in the study eye (e.g. uveitis,rod-cone dystrophy) or optic nerve * Area of macular retinal ischemia (as measured by the foveal avascular zone) ≥ 1000 μm. * Active intraocular inflammation (graded as trace or above) or active intraocular infection in either eye. * Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin \<10 g/dL for women and \<11 g/dL for men.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 91, 'type': 'ACTUAL'}}

2023-10-12