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

NCT ID: NCT03488550

Last Updated: 2020-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2018-08-03

Brief Summary

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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

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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.

Conditions

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Open-angle Glaucoma

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANX007-GLA-01

Group Type EXPERIMENTAL

ANX007

Intervention Type BIOLOGICAL

Single ascending dose

Interventions

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ANX007

Single ascending dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Annexon, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Humphriss

Role: STUDY_DIRECTOR

Annexon Vice President of Clinical Operations

Locations

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Eye Research Foundation

Newport Beach, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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ANX007-GLA-01

Identifier Type: -

Identifier Source: org_study_id

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