Back to resultsStudy 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
2.5mg ANX007
5.0mg ANX007
Sham Procedure
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 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Eye Research Foundation
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
2.5mg ANX007
5.0mg ANX007
Sham Procedure
Arm Description
1 in every 3 subjects will be randomized to 2.5mg dose of ANX007.
1 in every 3 subjects will be randomized to 5.0mg dose of ANX007.
1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007.
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of ANX007 in participants with primary open-angle glaucoma as measured by occurrence of treatment-emergent adverse events.
Secondary Outcome Measures
Evaluate PK parameters of ANX007 in serum after repeat injections
Maximum Serum Concentration (Cmax) of ANX007
Evaluate PK parameters of ANX007 in serum after repeat injections
Area Under the Curve (AUC) of ANX007
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Maximum aqueous humor Concentration (Cmax) of ANX007
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Aqueous humor Area Under the Curve (AUC) of ANX007
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Maximum C1q concentration (Cmax) in aqueous humor
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
C1q area under the curve (AUC) in aqueous humor
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Maximum C1q concentration (Cmax) in serum
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
C1q concentration area under the curve (AUC) in serum
Immunogenicity of ANX007 as measured by serum anti-drug antibodies (ADA) after repeat intravitreal injections of ANX007
Incidence of positive antibody titre against ANX007 in serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04188015
Brief Title
Study of ANX007 in Participants With Primary Open-angle Glaucoma
Official Title
A Phase 1b, Randomized, Double-masked, Sham-controlled Study of ANX007 Administered as Intravitreal Injections to Assess Safety and Tolerability 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
July 25, 2018 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2019 (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 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.
Detailed Description
This is a phase 1b, double-masked, sham-controlled study evaluating 2 dose levels of ANX007 administered as 2 IVT injections separated by 4 weeks. Approximately 15-29 subjects will be enrolled. An interim analysis of the initial set of 15 participants may be conducted. Based on this analysis, an additional 10-14 participants may be enrolled at a 1:1 ratio to receive one of the two dose levels.
The primary objective is to evaluate the safety and tolerability of repeat IVT injections of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the anterior chamber fluid pharmacokinetics (PK) of ANX007, PD effect of ANX007 on anterior chamber fluid C1q activity, and immunogenicity. An exploratory objective will evaluate ocular PD effect of ANX007.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2.5mg ANX007
Arm Type
Experimental
Arm Description
1 in every 3 subjects will be randomized to 2.5mg dose of ANX007.
Arm Title
5.0mg ANX007
Arm Type
Experimental
Arm Description
1 in every 3 subjects will be randomized to 5.0mg dose of ANX007.
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007.
Intervention Type
Biological
Intervention Name(s)
2.5mg ANX007
Intervention Description
A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
Intervention Type
Biological
Intervention Name(s)
5.0mg ANX007
Intervention Description
A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of ANX007 in participants with primary open-angle glaucoma as measured by occurrence of treatment-emergent adverse events.
Time Frame
Day 85
Secondary Outcome Measure Information:
Title
Evaluate PK parameters of ANX007 in serum after repeat injections
Description
Maximum Serum Concentration (Cmax) of ANX007
Time Frame
Day 29
Title
Evaluate PK parameters of ANX007 in serum after repeat injections
Description
Area Under the Curve (AUC) of ANX007
Time Frame
Day 29
Title
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Description
Maximum aqueous humor Concentration (Cmax) of ANX007
Time Frame
Day 29
Title
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Description
Aqueous humor Area Under the Curve (AUC) of ANX007
Time Frame
Day 29
Title
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Description
Maximum C1q concentration (Cmax) in aqueous humor
Time Frame
Day 29
Title
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Description
C1q area under the curve (AUC) in aqueous humor
Time Frame
Day 29
Title
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Description
Maximum C1q concentration (Cmax) in serum
Time Frame
Day 29
Title
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Description
C1q concentration area under the curve (AUC) in serum
Time Frame
Day 29
Title
Immunogenicity of ANX007 as measured by serum anti-drug antibodies (ADA) after repeat intravitreal injections of ANX007
Description
Incidence of positive antibody titre against ANX007 in serum
Time Frame
Day 84
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 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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Humphriss
Organizational Affiliation
Annexon Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.annexonbio.com
Description
Related Info
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Study of ANX007 in Participants With Primary Open-angle Glaucoma
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