Status:
WITHDRAWN
A Study of the Safety and Tolerability of Intravitreal LKA651 in Patients With Diabetic Macular Edema
Lead Sponsor:
Alcon Research
Collaborating Sponsors:
Novartis Institutes for BioMedical Research
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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 treatmen...
Detailed Description
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 LKA6...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02281292
Start Date
December 1 2015
End Date
June 1 2017
Last Update
December 11 2015
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