Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: LKA651; Lucentis
Intervention description: LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase; Lucentis 0.3 mg (U.S. sites) or 0.5 mg (ex U.S. sites) Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Macular degeneration; age-related macular degeneration (ARMD); vision loss; macula damage; retina damage; dry macular degeneration; wet macular degeneration; AMD; diabetic macular edema; DME; neovascular age-related macular degeneration; nAMD; retinal vein occlusion; RVO; Diabetic Macular edema (DME); macular edema; diabetic retinopathy; LKA651; Lucentis

Summary:

      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),
    

Eligibility criteria:

        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.