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Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration

NCT02507388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-07-02

Study results available
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Summary

The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (AMD).

Conditions

  • Neovascular Age-Related Macular Degeneration

Interventions

DRUG

Brolucizumab 3 mg/50 μL

Administered as an intravitreal injection

DRUG

Brolucizumab 6 mg/50 μL

Administered as an intravitreal injection

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Alcon, A Novartis Division · Alcon, A Novartis Division

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2016-09-06
Completion
2016-09-06
FDA Drug
Yes

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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 NCT02507388 on ClinicalTrials.gov