A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
NCT ID: NCT02867735
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2016-09-21
2018-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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LKA651
LKA651
Interventional
Sham Comparator
Sham Comparator
Interventions
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LKA651
Interventional
Sham Comparator
Eligibility Criteria
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Inclusion Criteria
The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)
Vital signs as specified within the protocol
Exclusion Criteria
Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C \> or = 12% at screening
other ocular conditions as specified in the protocol
systemic conditions as specified in the protocol
18 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Pasadena, California, United States
Novartis Investigative Site
Fort Myers, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Winter Haven, Florida, United States
Novartis Investigative Site
Augusta, Georgia, United States
Novartis Investigative Site
Arecibo, , Puerto Rico
Countries
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Other Identifiers
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CLKA651X2104
Identifier Type: -
Identifier Source: org_study_id
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