Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

• Status: Completed
• Trial end date: 2018-03-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Aflibercept; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Key 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.

Key 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.