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

NCT04919096 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-04-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

SCB-420

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.

DRUG

Aflibercept

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.

Sponsors & Collaborators

  • Clover Biopharmaceuticals AUS Pty

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2022-09-30
Completion
2023-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919096 on ClinicalTrials.gov