Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

• Status: Completed
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: All

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.

• 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 choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) that affected the central subfield in the study eye at Screening;

• Total area of CNV comprising >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 90-day period prior to Baseline.