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

• Status: Completed
• Trial end date: 2016-09-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research

Criteria

Inclusion Criteria:

• Provide written informed consent;

• Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye;

• Best Corrected Visual Acuity (BCVA) > 23 letters in the study eye at Baseline;

• 50 years of age or older at the time of Screening.

Exclusion Criteria:

• Any active ocular infection or inflammation;

• Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®), brolucizumab, or an investigational drug for neovascular AMD prior to enrollment in the study, as specified in protocol;

• Ocular surgery in the study eye, as specified in protocol;

• Uncontrolled glaucoma in the study eye, as specified in protocol;

• Use of steroids in the study eye, as specified in protocol;

• Medical conditions that may prevent study completion;

• Pregnant or nursing (lactating) women;

• Women of child-bearing potential unless using contraception;

• Uncontrolled blood pressure, as specified in protocol;

• Other protocol-specified exclusion criteria may apply.