Study of ANX007 in Participants With Primary Open-angle Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2019-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)

NCT01965106

Glaucoma, Angle-closure, Primary, Acute

COMPLETED PHASE2

Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT00691717

Open-angle Glaucoma Oular Hypertension

COMPLETED PHASE2/PHASE3

A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

NCT05495061

Primary Open Angle Glaucoma, Ocular Hypertension

COMPLETED PHASE3

Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

NCT00219596

Glaucoma, Open Angle Ocular Hypertension

COMPLETED PHASE3

Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

NCT02136940

Glaucoma Ocular Hypertension Eye Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2.5mg ANX007

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

Group Type EXPERIMENTAL

2.5mg ANX007

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

5.0mg ANX007

Intervention Type BIOLOGICAL

A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.

Sham Procedure

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

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No