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Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

NCT02461771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-10-06

Study results available
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Summary

The objective of this study is to provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of pegcetacoplan in order to support further development into larger Phase II studies for treatment of patients with AMD.

Conditions

  • Neovascular Age-Related Macular Degeneration

Interventions

DRUG

Pegcetacoplan

On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Sponsors & Collaborators

  • Apellis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Federico Grossi, MD PhD · Apellis Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-28
Primary Completion
2016-03-08
Completion
2016-03-08

Countries

  • United States
  • Australia

Study Locations

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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 NCT02461771 on ClinicalTrials.gov