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

Phase 1

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Biological: ANX007

• Registration Number: NCT03488550
• Lead Sponsor: Annexon, Inc.

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.

Study Timeline

• Study Start: 2018-03-23
• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-05
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ANX007-GLA-01	ANX007	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by the occurrence of adverse events	Day 56

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States