Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma

August 19, 2020 updated by: Annexon, Inc.

A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma

This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female age 18 years and older
  • Diagnosis of primary open-angle glaucoma
  • Intraocular pressure <21 mm Hg on a stable IOP treatment regimen
  • Reliable visual field testing

Exclusion Criteria:

  • BCVA worse than 20/80 in either eye
  • Extensive glaucomatous visual-field damage
  • History of intraocular inflammatory or infectious eye disease in study eye
  • Ocular trauma in study eye within the preceding 6 months
  • History of uncomplicated cataract surgery less than 6 mos prior
  • Any abnormality preventing reliable Tonopen tonometry in study eye
  • Active malignancy within past 5 yrs
  • Previous tx with another humanized monoclonal antibody
  • History of any autoimmune or neurologic disease
  • Concurrent use of glucocorticoid medications
  • Receiving monoamine oxidase inhibitor therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ANX007-GLA-01
Biological: ANX007
Single ascending dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as measured by the occurrence of adverse events
Time Frame: Day 56
Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum plasma concentration of ANX007 after a single IVT injection.
Time Frame: Day 15
Day 15
Immunogenicity of ANX007 after a single IVT injection.
Time Frame: Day 56
Day 56

Other Outcome Measures

Outcome Measure
Time Frame
Effect of a single IVT injection of ANX007 on serum C1q
Time Frame: Day 15
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Annexon, Inc.

Investigators

  • Study Director: Eric Humphriss, Annexon Vice President of Clinical Operations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2018

Primary Completion (ACTUAL)

August 3, 2018

Study Completion (ACTUAL)

August 3, 2018

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (ACTUAL)

April 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANX007-GLA-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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