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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03488550

Enrollment

Registered

2018-04-05

Start date

2018-03-23

Completion date

2018-08-03

Last updated

2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma

Brief summary

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.

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.

Interventions

BIOLOGICALANX007

Single ascending dose

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as measured by the occurrence of adverse events	Day 56

Secondary

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

Other

Measure	Time frame
Effect of a single IVT injection of ANX007 on serum C1q	Day 15

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026