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

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