A Study of the Safety and Tolerability of Intravitreal LKA651 in Patients With Diabetic Macular Edema

Sponsor
Alcon Research
Study ID
NCT02281292
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • LKA651 ophthalmic solution — BIOLOGICAL
  • Ranibizumab ophthalmic solution — BIOLOGICAL
  • Sham injection — BIOLOGICAL
    Mock injection administered as an empty hub without needle

Study Details

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.

Key Dates

First listed
Nov 3, 2014
Start date
Dec 31, 2015
Status verified
Dec 2015
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LKA651 (Part 1)
    LKA651 ophthalmic solution in 1 of 5 concentrations, administered as a single IVT injection in the study eye
  • Placebo Comparator: Sham injection (Part 1)
    Sham injection in the study eye
  • Experimental: LKA651 and Lucentis (Part 2)
    LKA651 ophthalmic solution in 1 of 3 concentrations, administered as a single IVT injection in the study eye, followed by ranibizumab ophthalmic solution, 0.5 mg injection in the same eye 30 minutes later
  • Placebo Comparator: Sham injection and Lucentis (Part 2)
    Sham injection in the study eye, followed by ranibizumab ophthalmic solution, 0.5 mg injection in the same eye 30 minutes later

Primary Outcome Measure

Number of subjects with a serious adverse event (SAE) that, in the opinion of the investigator, is related to the study drug [ Time Frame: Up to Day 85 ]

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