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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5mg ANX007 | Experimental | 1 in every 3 subjects will be randomized to 2.5mg dose of ANX007. |
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| 5.0mg ANX007 | Experimental | 1 in every 3 subjects will be randomized to 5.0mg dose of ANX007. |
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| Sham Procedure | Sham Comparator | 1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate PK parameters of ANX007 in serum after repeat injections | Maximum Serum Concentration (Cmax) of ANX007 | Day 29 |
| Evaluate PK parameters of ANX007 in serum after repeat injections | Area Under the Curve (AUC) of ANX007 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Humphriss | Annexon Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 94303 | United States | ||
| Stanford Health Care |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 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. |
|
| 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. |
|
| Day 29 |
| Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections | Maximum aqueous humor Concentration (Cmax) of ANX007 | Day 29 |
| Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections | Aqueous humor Area Under the Curve (AUC) of ANX007 | Day 29 |
| Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections | Maximum C1q concentration (Cmax) in aqueous humor | Day 29 |
| Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections | C1q area under the curve (AUC) in aqueous humor | Day 29 |
| Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections | Maximum C1q concentration (Cmax) in serum | Day 29 |
| Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections | C1q concentration area under the curve (AUC) in serum | Day 29 |
| 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 | Day 84 |
| Stanford |
| California |
| 94305 |
| United States |