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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Written informed consent must be obtained. - Type 1 or type 2 diabetes that is actively managed by a physician and hemoglobin A1C = 12% at screening/eligibility. - Negative pregnancy test results at screening/eligibility and pre-injection on treatment day. - Diabetic macular edema (DME) with center involvement in at least one eye, including those with focal or diffuse DME. - ETDRS letter score in the study eye of 55 letters or worse (approximate Snellen equivalent of 20/80). The non-study eye (fellow eye) should be = 60 letters or better (approximate Snellen equivalent of 20/63) at Day 1 pre-dose. - Safe to withhold treatment of the study eye with laser photocoagulation, intravitreal steroid injection, or intravitreal vascular endothelial growth factor (VEGF) inhibitor (Part 1) for the duration of the study. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than 1 disc area with no vitreous hemorrhage. - Any progressive disease of the retina (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g. glaucoma) other than diabetic retinopathy. - Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye. - Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia). - Cataract surgery in the study eye, Yttrium-Aluminum-Garnet (YAG) laser capsulotomy or any intraocular surgery within the past 6 months preceding Day 1. - Use of systemic anticoagulant therapy during the study, e.g., warfarin, heparin, etc. The use of aspirin is not an exclusion. - Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations. - Pregnant or nursing (lactating) women. - Women of child-bearing potential, unless using highly effective methods of contraception during dosing of study treatment. - Other protocol-defined exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Alcon Research | Novartis Institutes for BioMedical Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with a serious adverse event (SAE) that, in the opinion of the investigator, is related to the study drug | Up to Day 85 | Yes | |
Primary | Number of subjects experiencing a non-serious adverse event | Up to Day 85 | Yes | |
Secondary | The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUC(0-tlast)) | Contingent upon observed serum concentration levels | Up to Day 85 | No |
Secondary | The area under the serum concentration-time curve from time zero to time 't' where t is a defined time point after administration [mass x time / volume] (AUC (0-t)) | Contingent upon observed serum concentration levels | Up to Day 85 | No |
Secondary | The observed maximum serum concentration following drug administration [mass / volume] (Cmax) | Contingent upon observed serum concentration levels | Up to Day 85 | No |
Secondary | The time to reach the maximum serum concentration after drug administration [time] (Tmax) | Contingent upon observed serum concentration levels | Up to Day 85 | No |
Secondary | The dose normalized observed maximum serum concentration following drug administration [mass*dose / volume] (Cmax/D) | Contingent upon observed serum concentration levels | Up to Day 85 | No |
Secondary | The dose-normalized area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [mass*dose x time / volume] (AUC/D) | Up to Day 85 | No | |
Secondary | Central subfield thickness | Contingent upon observed serum concentration levels | Up to Day 85 | No |
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