Study of SCB-420 in Subjects With Neovascular Age-related Macular Degeneration

Sponsor
Clover Biopharmaceuticals AUS Pty
Study ID
NCT04919096
Phase
PHASE1
Status
Withdrawn

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SCB-420 — DRUG
    Subjects randomised to SCB-420 arm will receive a total of 3 doses of SCB-420 as an intravitreal injection of 2 mg into the study eye every 4 weeks on Day 1, Week 4, and Week 8.
  • Aflibercept — DRUG
    Subjects randomised to Aflibercept arm will receive a total of 3 doses of Aflibercept as an intravitreal injection of 2 mg into the study eye every 4 weeks on Day 1, Week 4, and Week 8.

Study Details

This is a Phase 1, randomized, double-masked, multicenter, parallel-assignment, pilot study to evaluate the safety, tolerability, initial clinical effectiveness, pharmacokinetics (PK), and immunogenicity of SCB-420 as compared with Eylea (aflibercept), in subjects with Neovascular Age-related Macular Degeneration. A total of 20 subjects with Neovascular Age-related Macular Degeneration will be enrolled across up to 11 sites in 3 countries (Australia, New Zealand, and China). The study will be conducted in 2 parts - Sentinel Safety Cohort and Open Enrolment. Subjects will be administered with 2 mg of SCB-420 or Eylea via intravitreal (IVT) injection every 4 weeks for a total 3 doses.

Key Dates

Start date
Apr 30, 2022
Status verified
Apr 2022
Primary completion
Sep 30, 2022
Completion
Jan 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCB-420
    Subjects randomized to SCB-420 will receive SCB-420 2mg (0.05 mL) via intravitreal injection in the study eye every 4 weeks for the first 3 months.
  • Active Comparator: Aflibercept
    Subjects randomized into Aflibercept (Eylea) group will receive Aflibercept (Eylea) 2 mg (0.05 mL) via intravitreal injection in the study eye every 4 weeks for the first 3 months.

Primary Outcome Measure

Incidence of ocular and non-ocular adverse events. [ Time Frame: Baseline to Week 12 ]

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