Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
- Conditions
- Open-angle Glaucoma
- Registration Number
- NCT03488550
- Lead Sponsor
- Annexon, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Safety and tolerability as measured by the occurrence of adverse events Day 56
- Secondary Outcome Measures
Name Time Method Serum plasma concentration of ANX007 after a single IVT injection. Day 15 Immunogenicity of ANX007 after a single IVT injection. Day 56
Trial Locations
- Locations (1)
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Eye Research Foundation🇺🇸Newport Beach, California, United States