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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
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.
Eye Research Foundation
Newport Beach, California, United States
Stanford Health Care
Stanford, California, United States
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
Evaluate PK parameters of ANX007 in serum after repeat injections
Maximum Serum Concentration (Cmax) of ANX007
Time frame: Day 29
Evaluate PK parameters of ANX007 in serum after repeat injections
Area Under the Curve (AUC) of ANX007
Time frame: Day 29
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Maximum aqueous humor Concentration (Cmax) of ANX007
Time frame: Day 29
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Aqueous humor Area Under the Curve (AUC) of ANX007
Time frame: Day 29
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Maximum C1q concentration (Cmax) in aqueous humor
Time frame: Day 29
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
C1q area under the curve (AUC) in aqueous humor
Time frame: Day 29
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Maximum C1q concentration (Cmax) in serum
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Time frame: Day 29
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
C1q concentration area under the curve (AUC) in serum
Time frame: 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
Time frame: Day 84