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

Open-angle Glaucoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488550
• Other study ID #: ANX007-GLA-01
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2018
• Est. completion date: August 3, 2018

Study information

• Verified date: August 2020
• Source: Annexon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Biological:
• ANX007
Single ascending dose

Locations

Country	Name	City	State
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Annexon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of a single IVT injection of ANX007 on serum C1q		Day 15
Primary	Safety and tolerability as measured by the occurrence of adverse events		Day 56
Secondary	Serum plasma concentration of ANX007 after a single IVT injection.		Day 15
Secondary	Immunogenicity of ANX007 after a single IVT injection.		Day 56

External Links

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