Study of ANX007 in Participants With Primary Open-angle Glaucoma
Completed · Phase 1 · Has a placebo group
Conditions studied: Open Angle Glaucoma
In brief
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.
Key facts
- Study ID
- NCT04188015
- Run by
- Annexon, Inc.
- People needed
- 17
- Starts
- 2018-07-25
- Expected to finish
- 2019-06-03
- Last updated by the study team
- 2020-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
Where it is running
- Eye Research Foundation — Newport Beach, California, United States
- Stanford Health Care — Stanford, California, United States
Full record on ClinicalTrials.gov
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