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 |
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.
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.
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
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sites
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Palo Alto, California 94303
Principal Investigator: Yang Sun, MD
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