Open Angle GlaucomaPhase 1NCT04188015
Study of ANX007 in Participants With Primary Open-angle Glaucoma
A Phase 1 study testing 2.5mg ANX007 and 5.0mg ANX007 in people with Open Angle Glaucoma, run by Annexon, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- 2.5mg ANX007 and 5.0mg ANX007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2018to 3 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 years, and above.
- Diagnosis of primary open-angle glaucoma.
- 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.
- Intraocular pressure (IOP) <21 mm Hg at screening and Day 1.
- 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.
- Ability to comply with the requirements of the study and complete the full sequence of protocol specified injections, procedures, and evaluations.
Who cannot join
- Extensive glaucomatous visual-field damage with a mean deviation worse than -18 dB on Humphrey visual field testing.
- 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.
- History of intraocular inflammatory or infectious eye disease in the study eye.
- Ocular trauma in the study eye within the preceding 6 months.
- 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.
- Any abnormality preventing reliable tonometry in the study eye.
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- 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.
- Receiving monoamine oxidase inhibitor therapy or patient-reported hypersensitivity to any component of apraclonidine, brimonidine, clonidine, phenylephrine, povidone iodine, proparacaine, or ANX007.
- Active or history of malignancy within the past 5 years with the exception of curatively treated, basal cell carcinoma.
- Previous treatment with another humanized monoclonal antibody, Fab or Fab'2.
- History of any autoimmune or neurologic disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eye Research Foundation
Newport Beach, California, 94303
Stanford Health Care
Stanford, California, 94305
About this study
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
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.
Read the 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.
- Conditions
- Open Angle Glaucoma
- Being tested
- 2.5mg ANX007, 5.0mg ANX007, Sham Procedure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5mg ANX007Biological
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 ANX007Biological
A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
Sham ProcedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 2.5mg ANX007 | Experimental | 1 in every 3 subjects will be randomized to 2.5mg dose of ANX007. Receives: Biological: 2.5mg ANX007 |
| 5.0mg ANX007 | Experimental | 1 in every 3 subjects will be randomized to 5.0mg dose of ANX007. Receives: Biological: 5.0mg ANX007 |
| Sham Procedure | Sham comparator | 1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007. Receives: Other: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ANX007 in participants with primary open-angle glaucoma as measured by occurrence of treatment-emergent adverse events.
Measured: Day 85
Secondary outcomes (9)
Evaluate PK parameters of ANX007 in serum after repeat injections
Maximum Serum Concentration (Cmax) of ANX007
Measured: Day 29
Evaluate PK parameters of ANX007 in serum after repeat injections
Area Under the Curve (AUC) of ANX007
Measured: Day 29
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Maximum aqueous humor Concentration (Cmax) of ANX007
Measured: Day 29
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Aqueous humor Area Under the Curve (AUC) of ANX007
Measured: Day 29
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Maximum C1q concentration (Cmax) in aqueous humor
Measured: Day 29
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
C1q area under the curve (AUC) in aqueous humor
Measured: Day 29
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Maximum C1q concentration (Cmax) in serum
Measured: Day 29
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
C1q concentration area under the curve (AUC) in serum
Measured: 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
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start25 Jul 2018
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Humphriss, Study director, Annexon Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188015
- Sponsor's protocol ID
- ANX007-GLA-02
- Status last verified
- Aug 2020
- First submitted
- 13 Dec 2018
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04188015
- Acronym / sponsor ID
- ANX007-GLA-02
- Conditions
- Open Angle Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.5mg ANX007 | Experimental | Biological: 2.5mg ANX0071 in every 3 subjects will be randomized to 2.5mg dose of ANX007. |
| 5.0mg ANX007 | Experimental | Biological: 5.0mg ANX0071 in every 3 subjects will be randomized to 5.0mg dose of ANX007. |
| Sham Procedure | Sham comparator | Other: Sham Procedure1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female age 18 years, and above.
- Diagnosis of primary open-angle glaucoma.
- 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.
- Intraocular pressure (IOP) <21 mm Hg at screening and Day 1.
- 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.
Key exclusion criteria (11 listed)
- Extensive glaucomatous visual-field damage with a mean deviation worse than -18 dB on Humphrey visual field testing.
- 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.
- History of intraocular inflammatory or infectious eye disease in the study eye.
- Ocular trauma in the study eye within the preceding 6 months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2.5mg ANX007A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29. | Biological | 2.5mg ANX007 |
| 5.0mg ANX007A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29. | Biological | 5.0mg ANX007 |
| Sham ProcedureThe 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. | Other | Sham Procedure |
Primary outcome
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
9 secondary outcomes
Evaluate PK parameters of ANX007 in serum after repeat injections
Time frame: Day 29
Evaluate PK parameters of ANX007 in serum after repeat injections
Time frame: Day 29
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Time frame: Day 29
Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections
Time frame: Day 29
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Time frame: Day 29
Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections
Time frame: Day 29
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Time frame: Day 29
Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections
Time frame: Day 29
Immunogenicity of ANX007 as measured by serum anti-drug antibodies (ADA) after repeat intravitreal injections of ANX007
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Humphriss study director
Annexon Biosciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2.5mg ANX007 and 5.0mg ANX007 in people with Open Angle Glaucoma, run by Annexon, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.