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

Alcon

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Brolucizumab 6 mg/50 μL; Drug: Brolucizumab 3 mg/50 μL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02507388

RTH258-E003

Details and patient eligibility

About

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).

Full description

This study has 2 arms with a 1:1 randomization. Randomization will be stratified by Japanese ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of the subjects in each arm will be non-Japanese. Subjects in both arms will have visits at Screening, Day 0 (Baseline), Day 1 (24 hours post first injection), Day 3, Day 14, Day 21, Day 28, Day 56, Day 57 (24 hours post the injection on Day 56) and Day 84.

Enrollment: 51 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Brolucizumab 3 mg

Experimental group

Description:

Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection

Treatment:

Drug: Brolucizumab 3 mg/50 μL

Brolucizumab 6 mg

Experimental group

Description:

Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection

Treatment:

Drug: Brolucizumab 6 mg/50 μL