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Study of ANX007 in Participants With Primary Open-angle Glaucoma

Sponsor
Annexon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04188015
Collaborator
(none)
17
Enrollment
2
Locations
3
Arms
10.3
Actual Duration (Months)
8.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: 2.5mg ANX007
  • Biological: 5.0mg ANX007
  • Other: Sham Procedure
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1b, Randomized, Double-masked, Sham-controlled Study of ANX007 Administered as Intravitreal Injections to Assess Safety and Tolerability in Participants With Primary Open-angle Glaucoma
Actual Study Start Date :
Jul 25, 2018
Actual Primary Completion Date :
Jun 3, 2019
Actual Study Completion Date :
Jun 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2.5mg ANX007

1 in every 3 subjects will be randomized to 2.5mg dose of ANX007.

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.
Experimental: 5.0mg ANX007

1 in every 3 subjects will be randomized to 5.0mg dose of ANX007.

Biological: 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.
Sham Comparator: Sham Procedure

1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007.

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Evaluate PK parameters of ANX007 in serum after repeat injections [Day 29]

    Maximum Serum Concentration (Cmax) of ANX007

  2. Evaluate PK parameters of ANX007 in serum after repeat injections [Day 29]

    Area Under the Curve (AUC) of ANX007

  3. Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections [Day 29]

    Maximum aqueous humor Concentration (Cmax) of ANX007

  4. Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections [Day 29]

    Aqueous humor Area Under the Curve (AUC) of ANX007

  5. Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections [Day 29]

    Maximum C1q concentration (Cmax) in aqueous humor

  6. Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections [Day 29]

    C1q area under the curve (AUC) in aqueous humor

  7. Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections [Day 29]

    Maximum C1q concentration (Cmax) in serum

  8. Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections [Day 29]

    C1q concentration area under the curve (AUC) in serum

  9. Immunogenicity of ANX007 as measured by serum anti-drug antibodies (ADA) after repeat intravitreal injections of ANX007 [Day 84]

    Incidence of positive antibody titre against ANX007 in serum

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Research Foundation Newport Beach California United States 94303
2 Stanford Health Care Stanford California United States 94305

Sponsors and Collaborators

  • Annexon, Inc.

Investigators

  • Study Director: Eric Humphriss, Annexon Biosciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Annexon, Inc.
ClinicalTrials.gov Identifier:
NCT04188015
Other Study ID Numbers:
  • ANX007-GLA-02
First Posted:
Dec 5, 2019
Last Update Posted:
Aug 20, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Aug 20, 2020