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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:March 23, 2018
End Date:August 3, 2018

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A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma

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.

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.

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
We found this trial at
2
sites
Palo Alto, California 94303
Principal Investigator: Yang Sun, MD
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Palo Alto, CA
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Newport Beach, California
Principal Investigator: David Wirta, MD
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Newport Beach, CA
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