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

NCT02281292 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-12-11

No results posted yet for this study

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 treatment of Diabetic Macular Edema (DME) in patients with symptomatic disease.

Conditions

Interventions

BIOLOGICAL

LKA651 ophthalmic solution

BIOLOGICAL

Ranibizumab ophthalmic solution

BIOLOGICAL

Sham injection

Mock injection administered as an empty hub without needle

Sponsors & Collaborators

  • Novartis Institutes for BioMedical Research

    collaborator OTHER

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Scientist, CSI, ID/Ophtha · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-06-30
Completion
2017-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281292 on ClinicalTrials.gov