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

Sponsor
Annexon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03488550
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
4.4
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: ANX007
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 23, 2018
Actual Primary Completion Date :
Aug 3, 2018
Actual Study Completion Date :
Aug 3, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANX007-GLA-01

Biological: ANX007
Single ascending dose

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability as measured by the occurrence of adverse events [Day 56]

Secondary Outcome Measures

  1. Serum plasma concentration of ANX007 after a single IVT injection. [Day 15]

  2. Immunogenicity of ANX007 after a single IVT injection. [Day 56]

Other Outcome Measures

  1. Effect of a single IVT injection of ANX007 on serum C1q [Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Research Foundation Newport Beach California United States 92663

Sponsors and Collaborators

  • Annexon, Inc.

Investigators

  • Study Director: Eric Humphriss, Annexon Vice President of Clinical Operations

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Annexon, Inc.
ClinicalTrials.gov Identifier:
NCT03488550
Other Study ID Numbers:
  • ANX007-GLA-01
First Posted:
Apr 5, 2018
Last Update Posted:
Aug 20, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Aug 20, 2020