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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04188015
Other study ID # ANX007-GLA-02
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 25, 2018
Est. completion date June 3, 2019

Study information

Verified date August 2020
Source Annexon, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date June 3, 2019
Est. primary completion date June 3, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female age 18 years, and above.

2. Diagnosis of primary open-angle glaucoma.

3. Ability to perform a reliable visual field test in the study eye with a cutoff of 33% for fixation losses and 33% for false-positive response rates.

4. Intraocular pressure (IOP) <21 mm Hg at screening and Day 1.

5. The IOP treatment regimen in the study eye should be stable for at least 4 weeks prior to injection, with no change in the IOP treatment regimen anticipated throughout study participation.

6. Ability to comply with the requirements of the study and complete the full sequence of protocol specified injections, procedures, and evaluations.

Exclusion Criteria:

1. Extensive glaucomatous visual-field damage with a mean deviation worse than -18 dB on Humphrey visual field testing.

2. Any current or prior ocular pathology, other than glaucoma, which could interfere with the conduct of the study including, but not limited to, retinal or optic nerve disease and media opacity in the study eye.

3. History of intraocular inflammatory or infectious eye disease in the study eye.

4. Ocular trauma in the study eye within the preceding 6 months.

5. A history of uncomplicated cataract surgery less than 3 months prior to injection, or trabeculectomy, iridotomy, or other ocular procedures in the study eye that could affect drug distribution and excretion.

6. Any abnormality preventing reliable tonometry in the study eye.

7. Concurrent use of glucocorticoid medications administered by any ocular or systemic route. Nasal, inhaled, and dermatologic (if not administered around the eyes) glucocorticoids are permitted.

8. Receiving monoamine oxidase inhibitor therapy or patient-reported hypersensitivity to any component of apraclonidine, brimonidine, clonidine, phenylephrine, povidone iodine, proparacaine, or ANX007.

9. Active or history of malignancy within the past 5 years with the exception of curatively treated, basal cell carcinoma.

10. Previous treatment with another humanized monoclonal antibody, Fab or Fab'2.

11. History of any autoimmune or neurologic disease.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
2.5mg ANX007
A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
5.0mg ANX007
A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
Other:
Sham Procedure
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.

Locations

Country Name City State
United States Eye Research Foundation Newport Beach California
United States Stanford Health Care Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Annexon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Evaluate PK parameters of ANX007 in serum after repeat injections Maximum Serum Concentration (Cmax) of ANX007 Day 29
Secondary Evaluate PK parameters of ANX007 in serum after repeat injections Area Under the Curve (AUC) of ANX007 Day 29
Secondary Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections Maximum aqueous humor Concentration (Cmax) of ANX007 Day 29
Secondary Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections Aqueous humor Area Under the Curve (AUC) of ANX007 Day 29
Secondary Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections Maximum C1q concentration (Cmax) in aqueous humor Day 29
Secondary Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections C1q area under the curve (AUC) in aqueous humor Day 29
Secondary Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections Maximum C1q concentration (Cmax) in serum Day 29
Secondary Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections C1q concentration area under the curve (AUC) in serum Day 29
Secondary 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
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