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Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

NCT02307682 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1775

Last updated 2025-01-16

Study results available
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Summary

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.

Conditions

  • Neovascular Age-Related Macular Degeneration
  • Choroidal Neovascularization

Interventions

DRUG

Brolucizumab ophthalmic solution

Ophthalmic solution for IVT injection

DRUG

Aflibercept ophthalmic solution

Ophthalmic solution for IVT injection

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Group Trial Lead · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2017-04-22
Completion
2018-03-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02307682 on ClinicalTrials.gov