Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?

An observational study of Glaucoma, run by Wills Eye.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study was to evaluate structural and functional improvement after lowering intraocular pressure (IOP) in patients with glaucoma using Spectral Domain Optical Coherence Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked Potential (VEP). Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Glaucoma
What is being tested?: Optical Coherence Tomography (OCT), Visual evoked potential (VEP) and Humphrey Visual Field (HVF)
How many people: 61 participants
Where: No sites listed yet
Study dates: Oct 2011to Jan 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Glaucoma patients with intraocular pressure (IOP) between 22 and 32 millimeters of mercury (mm HG); greater than 32 mm HG; and with stable IOPs (control group).

Who may be able to join

All patients with glaucoma (primary open-angle glaucoma, angle recession glaucoma, exfoliation syndrome glaucoma, pigmentary glaucoma and chronic angle closure glaucoma) in whom a pressure-lowering intervention was conducted

Who cannot join

Inability to obtain reliable field or optical coherence tomography pre-intervention
Visual acuity less than 20/40,
Age <18 or >90 years,
Other cause for visual field loss not glaucoma, that is, visual field loss due to cataract optic neuropathies, retinal disease
Spherical equivalent refractive error > +5.00 Diopters and > 3.00 Diopters cylinder
Concomitant cataract and glaucoma surgery

About this study

Official title: Reversible Structural and Functional Changes After Intraocular Pressure Reduction in Patients With Glaucoma

Read the detailed description

Glaucoma exhibits characteristic changes to the optic nerve in the back of the eye. The optic nerve is formed when fibers that overlay the retina come together. This layer is called the retinal nerve fiber layer (RNFL).

Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers in the retina and RNFL. This provides important anatomical information.

VEP (visual evoked potential) is an imaging system that measures electrical signals from the eye to the brain by using electrodes placed on the forehead and back of head. This is similar in principal to an electrocardiogram of the heart.

Visual field testing is done to evaluate the extent of side vision loss caused by various diseases of the eye, including glaucoma. This testing is performed as you stare at a small light directly in front of your eye while lights flash one at a time in every direction on a screen surrounding the central light. You push a button each time you see a flash out of the corner of your eye.

Lowering intraocular pressure (IOP) in the eye has been shown to result in reversal of glaucoma changes of the optic nerve in some patients. It has also been suggested that improvement in function (visual field) has been associated with improved optic nerve appearance.

This study seeks to provide evidence for reversal of disc appearance and visual function following IOP lowering interventions.

Conditions: Glaucoma
Being tested: Optical Coherence Tomography (OCT), Visual evoked potential (VEP), Humphrey Visual Field (HVF)
Keywords: Visual Evoked Potentials, Optical Coherence Tomography, Visual Fields
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optical Coherence Tomography (OCT)Diagnostic test
Also called OCT
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).
Visual evoked potential (VEP)Diagnostic test
Also called VEP
Visual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).
Humphrey Visual Field (HVF)Diagnostic test
Also called VF
Humphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.

Study groups in NCT02600403
Study group	Role	What they receive
IOP between 22-32 mmHg		Forty four (44) patients with intraocular pressure between 22 and 32 millimeters (mmHg) of mercury will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF). Receives: Diagnostic Test: Optical Coherence Tomography (OCT); Diagnostic Test: Visual evoked potential (VEP); Diagnostic Test: Humphrey Visual Field (HVF)
IOP greater than 32 mmHg		Six (6) patients with intraocular pressure greater than 32 millimeters of mercury (mmHg) will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF). Receives: Diagnostic Test: Optical Coherence Tomography (OCT); Diagnostic Test: Visual evoked potential (VEP); Diagnostic Test: Humphrey Visual Field (HVF)
IOP less than 22 mmHg		Eleven (11) patients with stable intraocular pressure (less than 22 millimeters of mercury (mmHg)) on ophthalmic solutions (eye drops) will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF). Receives: Diagnostic Test: Optical Coherence Tomography (OCT); Diagnostic Test: Visual evoked potential (VEP); Diagnostic Test: Humphrey Visual Field (HVF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Field Mean Deviation
Visual field mean deviation as measured in decibels (dB) is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. Brighter light has lower number in decibels. The dimmer the light, the higher the number in decibels with a range of 0 to 40 dB.
Measured: 12 months
Retinal Nerve Fiber Layer (RNFL) Thickness Measurement
Retinal nerve fiber layer (RNFL) thickness in different quadrants of optic nerve and macula are measured pre and postoperatively to evaluate structural changes.
Measured: 12 months
Average Cup to Disc Ratio
Cup to disc ratio is used to evaluate structural changes comparing the size of the cup to the size of the disc during dilated ophthalmic examination. High eye pressure can cause the cup to enlarge, closer to the size of the disc. This measurement is used to follow progression in glaucoma. A normal range for cup to disc ratio would be 0.0 to 0.4. Advanced glaucoma would be 0.8 to 0.9 cup to disc ratio.
Measured: 12 months
Visual Evoked Potential Amplitudes
VEP amplitudes at high contrast as measured in microvolts (μV). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. The amplitude measurement is the peak of the energy generated (strongest strength of the signal) from the eye's response to the visual stimulus during the VEP.
Measured: 12 months
Visual Evoked Potential Latency
VEP latency at high contrast as measured in milliseconds (ms). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. VEP latencies measure the duration in time of the energy generated (duration of the signal) from the eye's response to a visual stimulus during the VEP.
Measured: 12 months
Visual Field
Visual field pattern standard deviation in decibels (dB). Visual field results compare visual field loss to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. With a localized defect in the visual field, pattern standard deviation (PSD) quantifies amount of loss and progression of glaucoma when in the beginning stages of the disease.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jan 2013

First posted9 Nov 2015 (estimated)
Study startOct 2011
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02600403
Sponsor's protocol ID: 11-058
Status last verified: Mar 2018
First submitted: 10 Aug 2015
Last updated: 19 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jindal AP, Fleischman D, Leiby B, Spaeth GL, Myers JS, Katz LJ. Effects of acutely lowering intraocular pressure on the results of multifocal visual evoked potential testing. Acta Ophthalmol. 2011 Nov;89(7):e550-4. doi: 10.1111/j.1755-3768.2011.02177.x. Epub 2011 May 23.
PubMed 21599873
Waisbourd M, Ahmed OM, Molineaux J, Gonzalez A, Spaeth GL, Katz LJ. Reversible structural and functional changes after intraocular pressure reduction in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2016 Jun;254(6):1159-66. doi: 10.1007/s00417-016-3321-2. Epub 2016 Mar 19.
PubMed 26995555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reversible Structural and Functional Changes After Intraocular Pressure Reduction in Patients With Glaucoma
ClinicalTrials.gov ID: NCT02600403
Acronym / sponsor ID: 11-058
Conditions: Glaucoma
Keywords: Visual Evoked Potentials, Optical Coherence Tomography, Visual Fields
Study type: Observational
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Wills EyeUniversity, hospital or other
Study start: Oct 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 9 Nov 2015 (estimated)
Results: Posted 19 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers in the retina and RNFL. This provides important anatomical information.

This study seeks to provide evidence for reversal of disc appearance and visual function following IOP lowering interventions.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
IOP between 22-32 mmHg	–	Diagnostic Test: Optical Coherence Tomography (OCT), Diagnostic Test: Visual evoked potential (VEP), Diagnostic Test: Humphrey Visual Field (HVF)Forty four (44) patients with intraocular pressure between 22 and 32 millimeters (mmHg) of mercury will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF).
IOP greater than 32 mmHg	–	Diagnostic Test: Optical Coherence Tomography (OCT), Diagnostic Test: Visual evoked potential (VEP), Diagnostic Test: Humphrey Visual Field (HVF)Six (6) patients with intraocular pressure greater than 32 millimeters of mercury (mmHg) will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF).
IOP less than 22 mmHg	–	Diagnostic Test: Optical Coherence Tomography (OCT), Diagnostic Test: Visual evoked potential (VEP), Diagnostic Test: Humphrey Visual Field (HVF)Eleven (11) patients with stable intraocular pressure (less than 22 millimeters of mercury (mmHg)) on ophthalmic solutions (eye drops) will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Glaucoma patients with intraocular pressure (IOP) between 22 and 32 millimeters of mercury (mm HG); greater than 32 mm HG; and with stable IOPs (control group).

Key inclusion criteria (1 listed)

All patients with glaucoma (primary open-angle glaucoma, angle recession glaucoma, exfoliation syndrome glaucoma, pigmentary glaucoma and chronic angle closure glaucoma) in whom a pressure-lowering intervention was conducted

Key exclusion criteria (6 listed)

Inability to obtain reliable field or optical coherence tomography pre-intervention
Visual acuity less than 20/40,
Age <18 or >90 years,
Other cause for visual field loss not glaucoma, that is, visual field loss due to cataract optic neuropathies, retinal disease
Spherical equivalent refractive error > +5.00 Diopters and > 3.00 Diopters cylinder

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
Optical Coherence Tomography (OCT)Also: OCTOptical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).	Diagnostic test	IOP between 22-32 mmHg, IOP greater than 32 mmHg, IOP less than 22 mmHg
Visual evoked potential (VEP)Also: VEPVisual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).	Diagnostic test	IOP between 22-32 mmHg, IOP greater than 32 mmHg, IOP less than 22 mmHg
Humphrey Visual Field (HVF)Also: VFHumphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.	Diagnostic test	IOP between 22-32 mmHg, IOP greater than 32 mmHg, IOP less than 22 mmHg

Primary outcome

Visual Field Mean Deviation
Time frame: 12 months
Visual field mean deviation as measured in decibels (dB) is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. Brighter light has lower number in decibels. The dimmer the light, the higher the number in decibels with a range of 0 to 40 dB.
Retinal Nerve Fiber Layer (RNFL) Thickness Measurement
Time frame: 12 months
Retinal nerve fiber layer (RNFL) thickness in different quadrants of optic nerve and macula are measured pre and postoperatively to evaluate structural changes.
Average Cup to Disc Ratio
Time frame: 12 months
Cup to disc ratio is used to evaluate structural changes comparing the size of the cup to the size of the disc during dilated ophthalmic examination. High eye pressure can cause the cup to enlarge, closer to the size of the disc. This measurement is used to follow progression in glaucoma. A normal range for cup to disc ratio would be 0.0 to 0.4. Advanced glaucoma would be 0.8 to 0.9 cup to disc ratio.
Visual Evoked Potential Amplitudes
Time frame: 12 months
VEP amplitudes at high contrast as measured in microvolts (μV). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. The amplitude measurement is the peak of the energy generated (strongest strength of the signal) from the eye's response to the visual stimulus during the VEP.
Visual Evoked Potential Latency
Time frame: 12 months
VEP latency at high contrast as measured in milliseconds (ms). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. VEP latencies measure the duration in time of the energy generated (duration of the signal) from the eye's response to a visual stimulus during the VEP.
Visual Field
Time frame: 12 months
Visual field pattern standard deviation in decibels (dB). Visual field results compare visual field loss to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. With a localized defect in the visual field, pattern standard deviation (PSD) quantifies amount of loss and progression of glaucoma when in the beginning stages of the disease.

Results and safety

Results posted to the registry on 19 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glaucoma Subjects With IOP 22-32 mmHg	44	44
Glaucoma Subjects With IOP >32 mmHg	6	6
Control Glaucoma Subjects	11	11

Primary outcome: Visual Field Mean Deviation

Time frame: 12 months. Mean (Standard Deviation). Unit: dB (decibels)

Measure	Glaucoma Subjects With IOP 22-32 mmHg n = 44	Glaucoma Subjects With IOP >32 mmHg n = 6	Control Glaucoma Subjects n = 11
Pre-operative	-8.7 (8.2)	-13.3 (9.7)	-13.2 (10.6)
Follow up 1	-8.3 (7.84)	-14.1 (10.15)	-8.6 (7.87)
Follow up 2	-8.5 (7.19)	-13.8 (10.66)	-9.4 (7.68)
Follow up 3	-9.4 (8.5)	-14.8 (12.2)	-10.4 (7.4)

Primary outcome: Retinal Nerve Fiber Layer (RNFL) Thickness Measurement

Time frame: 12 months. Mean (Standard Deviation). Unit: um

Measure	Glaucoma Subjects With IOP 22-32 mmHg n = 44	Glaucoma Subjects With IOP >32 mmHg n = 6	Control Glaucoma Subjects n = 11
Pre-operative	75.5 (16.1)	74.3 (10.2)	70.4 (11.7)
Follow up 1	74.9 (15.22)	76 (9.08)	69.4 (2.05)
Follow up 2	73.8 (20.53)	75.2 (9.75)	68.9 (0)
Follow up 3	74.7 (11.03)	74.1 (10.68)	67.4 (0.5)

Primary outcome: Average Cup to Disc Ratio

Time frame: 12 months. Mean (Standard Deviation). Unit: ratio

Measure	Glaucoma Subjects With IOP 22-32 mmHg n = 44	Glaucoma Subjects With IOP >32 mmHg n = 6	Control Glaucoma Subjects n = 11
Pre-operative	0.71 (0.12)	0.76 (0.17)	0.76 (0.09)
Follow up 1	0.69 (0.17)	0.74 (0.20)	0.77 (0.034)
Follow up 2	0.68 (0.20)	0.72 (0.19)	0.75 (0)
Follow up 3	0.68 (0.08)	0.72 (0.22)	0.77 (0.01)

Primary outcome: Visual Evoked Potential Amplitudes

Time frame: 12 months. Mean (Standard Deviation). Unit: micro volts (uV)

Measure	Glaucoma Subjects With IOP 22-32 mmHg n = 44	Glaucoma Subjects With IOP >32 mmHg n = 6	Control Glaucoma Subjects n = 11
Pre-operative Amplitude High Contrast	12.7 (14.4)	10.7 (5.4)	12.1 (8.33)
Follow up 1 Amplitude High Contrast	12.1 (6.73)	9.5 (1.78)	12.5 (8.6)
Follow up 2 Amplitude High Contrast	12.4 (3.34)	9.2 (4.56)	NA (NA)
Follow up 3 Amplitude High Contrast	11.8 (4.3)	12.1 (5.5)	NA (NA)

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glaucoma Subjects With IOP 22-32 mmHg	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Glaucoma Subjects With IOP >32 mmHg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Control Glaucoma Subjects	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Limitations and caveats (from the sponsor): Small sample size. Patients grouped by baseline intraocular pressure not by intervention. Inconsistent follow-up times. Subset of moderate to advanced glaucoma precluding possibility of reversible VEP changes in earlier stages of glaucoma.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21599873Jindal AP, Fleischman D, Leiby B, Spaeth GL, Myers JS, Katz LJ. Effects of acutely lowering intraocular pressure on the results of multifocal visual evoked potential testing. Acta Ophthalmol. 2011 Nov;89(7):e550-4. doi: 10.1111/j.1755-3768.2011.02177.x. Epub 2011 May 23.
Background: PubMed 26995555Waisbourd M, Ahmed OM, Molineaux J, Gonzalez A, Spaeth GL, Katz LJ. Reversible structural and functional changes after intraocular pressure reduction in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2016 Jun;254(6):1159-66. doi: 10.1007/s00417-016-3321-2. Epub 2016 Mar 19.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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RecruitingObservational study
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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.

George Spaeth, MD principal investigator

Wills Eye

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Wills Eye.

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 1 inclusion and 6 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Visual Field Mean Deviation (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02600403, which also lists 2 linked publications.

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 19 Mar 2018.