Efficacy and Safety of RTH258 Versus Aflibercept

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1048 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-28

Study Completion Date

2018-03-08

Brief Summary

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The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (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.

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Detailed Description

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Subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. Subjects in both treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks.

Subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study.

Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study.

Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).

Conditions

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Neovascular Age-Related Macular Degeneration Choroidal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brolucizumab 6 mg

Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit

Group Type EXPERIMENTAL

Brolucizumab ophthalmic solution

Intervention Type DRUG

Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose

Aflibercept 2 mg

Single IVT injection of aflibercept ophthalmic solution at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit

Group Type ACTIVE_COMPARATOR

Aflibercept ophthalmic solution

Intervention Type DRUG

Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose

Interventions

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Brolucizumab ophthalmic solution

Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose

Intervention Type DRUG

Aflibercept ophthalmic solution

Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose

Intervention Type DRUG

Other Intervention Names

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RTH258 EYLEA®

Eligibility Criteria

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Inclusion Criteria

* Provide written informed consent;
* Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening;
* Total area of CNV \> 50% of the total lesion area in the study eye at Screening;
* Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening;
* Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

Exclusion Criteria

* Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline;
* Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at Screening;
* Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at Screening;
* Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time;
* Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline;
* Pregnant or nursing women; women of child-bearing potential;
* Stroke or myocardial infarction in the 6-month period prior to Baseline.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No