Diabetic Macular Edema Clinical Trial
Official title:
A Randomized, Sham Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Diabetic Macular Edema
The purpose of this study is to evaluate the initial safety of intravitreal (IVT) LKA651 and potential for use alone or in combination with Ranibizumab ophthalmic solution (Lucentis®) for the treatment of Diabetic Macular Edema (DME) in patients with symptomatic disease.
This first-in-human study will be conducted in 2 parts. Part 1 is an ascending dose design
to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of various single
IVT doses of LKA651 in up to 48 subjects with diabetic macular edema. Subjects will be
randomized to receive active or sham injections in a 3:1 ratio. A total of 6 cohorts (8
subjects per cohort) may be enrolled in Part 1. Each subject will participate in a
screening/eligibility period (up to 60 days), a treatment period (single day), and an 84 day
follow up period. A total of up to 11 visits will take place, all on an out-patient basis.
An independent data monitoring committee (DMC) will be chartered to review cumulative safety
data and approve each dose escalation and cohort progression in this first-in-human trial.
Part 2 is a double-masked design to assess the safety/tolerability, pharmacokinetics and
pharmacodynamics of a single IVT dose of LKA651 when co-administered with Lucentis®. A total
of up to 3 cohorts (8 subjects per cohort) may be enrolled in Part 2. Each subject will
participate in a screening/eligibility period (up to 60 days), a treatment period
(combination therapy, single day), and an 84 day follow up period. A total of up to 11
visits will take place, all on an out-patient basis. For the LKA651 vs sham injections, the
unmasked ophthalmologist is not permitted to do any of the assessments except for the
injection (and an inspection of the injection site immediately following). All other ocular
assessments after randomization will be conducted by a second ophthalmologist masked to the
type of injection (active or sham). The Lucentis injection (Part 2) is given open label to
all patients following either the LKA651 or sham injection.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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