Overview

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.