Back to resultsSingle-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
Primary Purpose
Open-angle Glaucoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ANX007
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
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
Sites / Locations
- Eye Research Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ANX007-GLA-01
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability as measured by the occurrence of adverse events
Secondary Outcome Measures
Serum plasma concentration of ANX007 after a single IVT injection.
Immunogenicity of ANX007 after a single IVT injection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03488550
Brief Title
Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
August 3, 2018 (Actual)
Study Completion Date
August 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Annexon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ANX007-GLA-01
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ANX007
Intervention Description
Single ascending dose
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by the occurrence of adverse events
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Serum plasma concentration of ANX007 after a single IVT injection.
Time Frame
Day 15
Title
Immunogenicity of ANX007 after a single IVT injection.
Time Frame
Day 56
Other Pre-specified Outcome Measures:
Title
Effect of a single IVT injection of ANX007 on serum C1q
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Humphriss
Organizational Affiliation
Annexon Vice President of Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.annexonbio.com
Description
Related Info
Learn more about this trial
Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
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