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OpenTrials
Completed

NCT Number: NCT03488550

Single-dose Study of 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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eye Research Foundation

Newport Beach, California, 92663, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANX007

Biological

Single ascending dose

Primary outcomes

  1. Safety and tolerability as measured by the occurrence of adverse events

    Time frame: Day 56

Secondary outcomes

  1. Serum plasma concentration of ANX007 after a single IVT injection.

    Time frame: Day 15

  2. Immunogenicity of ANX007 after a single IVT injection.

    Time frame: Day 56

Other outcomes

  1. Effect of a single IVT injection of ANX007 on serum C1q

    Time frame: Day 15

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2018
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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