Study of ANX007 in Participants With Primary Open-angle Glaucoma

NCT04188015 | Completed Phase 1 FDA Drug

• 1 other identifier: ANX007-GLA-02
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

This is a double-masked, randomized, sham-controlled study evaluating two dose levels of ANX007 vs sham, administered as repeat Intravitreal (IVT) injections in patients with Primary Open-angle Glaucoma.

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of ANX007 in participants with primary open-angle glaucoma as measured by occurrence of treatment-emergent adverse events.

  Day 85

Secondary Outcomes (9)

• Evaluate PK parameters of ANX007 in serum after repeat injections

  Day 29

• Evaluate PK parameters of ANX007 in serum after repeat injections

  Day 29

• Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections

  Day 29

• Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections

  Day 29

• Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections

  Day 29

Study Arms (3)

2.5mg ANX007

EXPERIMENTAL

1 in every 3 subjects will be randomized to 2.5mg dose of ANX007.

Biological: 2.5mg ANX007

5.0mg ANX007

EXPERIMENTAL

1 in every 3 subjects will be randomized to 5.0mg dose of ANX007.

Biological: 5.0mg ANX007

Sham Procedure

SHAM COMPARATOR

1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007.

Other: Sham Procedure

Interventions

2.5mg ANX007 BIOLOGICAL

A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.

2.5mg ANX007

5.0mg ANX007 BIOLOGICAL

A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.

5.0mg ANX007

Sham Procedure OTHER

The sham injection is preformed by applying pressure to the eye at the location of a typical IVT injection using the blunt end of a syringe without a needle.

Sham Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 years, and above.
• Diagnosis of primary open-angle glaucoma.
• Ability to perform a reliable visual field test in the study eye with a cutoff of 33% for fixation losses and 33% for false-positive response rates.
• Intraocular pressure (IOP) \<21 mm Hg at screening and Day 1.
• The IOP treatment regimen in the study eye should be stable for at least 4 weeks prior to injection, with no change in the IOP treatment regimen anticipated throughout study participation.
• Ability to comply with the requirements of the study and complete the full sequence of protocol specified injections, procedures, and evaluations.

You may not qualify if:

• Extensive glaucomatous visual-field damage with a mean deviation worse than -18 dB on Humphrey visual field testing.
• Any current or prior ocular pathology, other than glaucoma, which could interfere with the conduct of the study including, but not limited to, retinal or optic nerve disease and media opacity in the study eye.
• History of intraocular inflammatory or infectious eye disease in the study eye.
• Ocular trauma in the study eye within the preceding 6 months.
• A history of uncomplicated cataract surgery less than 3 months prior to injection, or trabeculectomy, iridotomy, or other ocular procedures in the study eye that could affect drug distribution and excretion.
• Any abnormality preventing reliable tonometry in the study eye.
• Concurrent use of glucocorticoid medications administered by any ocular or systemic route. Nasal, inhaled, and dermatologic (if not administered around the eyes) glucocorticoids are permitted.
• Receiving monoamine oxidase inhibitor therapy or patient-reported hypersensitivity to any component of apraclonidine, brimonidine, clonidine, phenylephrine, povidone iodine, proparacaine, or ANX007.
• Active or history of malignancy within the past 5 years with the exception of curatively treated, basal cell carcinoma.
• Previous treatment with another humanized monoclonal antibody, Fab or Fab'2.
• History of any autoimmune or neurologic disease.

Sponsors & Collaborators

• Annexon, Inc.: lead

Study Sites (2)

Eye Research Foundation

Newport Beach, California, 94303, United States

Location

Stanford Health Care

Stanford, California, 94305, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Eric Humphriss

  Annexon Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 5, 2019
• Study Start: July 25, 2018
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

US (2)