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

A

Annexon

Status and phase

Completed
Phase 1

Conditions

Open-angle Glaucoma

Treatments

Biological: ANX007

Study type

Interventional

Funder types

Industry

Identifiers

NCT03488550
ANX007-GLA-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

9 participants in 1 patient group

ANX007-GLA-01
Experimental group
Treatment:
Biological: ANX007

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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