GlaucomaCINEXENNCT04781283
Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma
A study testing measurement of endothelial cell density by specular microscopy in people with Glaucoma, run by Fondation Hôpital Saint-Joseph.
Trial summary
Glaucoma is a blinding optic neuropathy that affects 60 million people worldwide. Of all the types of existing glaucoma, primary open-angle glaucoma is the most common etiology. The therapeutic arsenal today includes drug lowering treatments, lasers and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- measurement of endothelial cell density by specular microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2021to 15 Nov 2021
- Phase
- Interventional
- 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
- Man or woman aged ≥ 18 years
- French-speaking patient
- Patients followed for primary or secondary open-angle glaucoma in the ophthalmology department of the GhPSJ
- Patient with an indication for surgery with placement of Xen® or NDPS alone or combined with cataract surgery by phacoemulsification of the lens
- Patient affiliated to social security or, failing that, to another health insurance system
- Patient capable of giving free, informed and express consent.
Who cannot join
- Patient with another associated ophthalmological disease, apart from a simple cataract already operated on or operated simultaneously with NDPS or the Xen® break without complications during or after the operation
- History of filtering surgery, history of vitrectomy
- Closed-angle glaucoma
- Pseudo capsular exfoliation (connective tissue disease affecting the eye)
- Uveitic glaucoma (glaucoma related to inflammation which can itself have an effect on the cornea)
- Prolonged postoperative hypertonia (7 days)> 40 mmHG (because this can damage the cells of the cornea)
Show all 12Show fewer
- Pre-existing endothelial dystrophy, irido-corneo-endothelial syndrome (ICE) (glaucoma with corneal pathology)
- Postoperative athalamy (contact between the iris and the cornea generating endothelial cell loss)
- Endothelial cell count <1000 cells
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection.
About this study
Official title: Prospective Randomized Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma
Glaucoma is a blinding optic neuropathy that affects 60 million people worldwide. Of all the types of existing glaucoma, primary open-angle glaucoma is the most common etiology. The therapeutic arsenal today includes drug lowering treatments, lasers and surgery. The most frequent glaucoma surgeries are, in France, trabeculectomy and non-perforating deep sclerectomy (NPDS). These are two filtering surgeries whose principle is to lower the intra ocular pressure (IOP) by creating an evacuation path of the aqueous humor from the anterior chamber (AC) of the eye to the space subconjunctival creating a filtration bubble (FB). These two procedures are currently considered the gold standard. They can be performed alone or at the same time as cataract surgery. The short-term complications encountered with these techniques are early hypotonia and its attendant complications (choroidal detachment, hypotonic maculopathy, hemorrhages, etc.), the most common cause of which is conjunctival leakage from the bubble. In the medium term, increases in blood pressure with deep AC testify to a scleral flap that is too tight which may require suture lysis. Finally, the problems of excessive conjunctival-Tenon healing concern 25 to 30% of those operated on and are responsible for the majority of late blood pressure increases. In the longer term, the most common complication is cataracts; the rarest, but most serious complication is infection of BF, which occurs more readily when the walls of the FB are ischemic or even perforated. It can be complicated by an extremely serious endophthalmitis. A new minimally invasive therapeutic option has been developed limiting per- and post-operative complications. Unlike traditional techniques which present an ab externo approach, the ab interno approach of the new technique proposed consists of the implantation of a tube of collagen 6 mm in length and 45 µm of light called Xen® through the AC .
Read the detailed description
This surgery can be performed alone or at the same time as cataract surgery. The geometry of the Xen® implant has been studied to help prevent major hypotonia. This new technique would also prevent complications related to conjunctival dissection, while being faster. The placement of a Xen® implant is now used in simple surgery or combined with cataract surgery for open-angle glaucomas, beginners to moderate, associated or not with cataract, progressive and unbalanced under local hypotonizing treatment. Since June 2017, the Xen® technique has been part of the routine in the ophthalmology department of the Paris Saint-Joseph Hospital Group (GhPSJ). The choice of technique (filtering surgery or XEN®) is left to the discretion of the surgeon. To date, no study has yet compared the efficacy and safety of this new technique compared to non-perforating deep sclerectomy: the gold standard. However, the presence of any type of anterior chamber device may be associated with endothelial cell loss even when the device is not in direct contact with the cornea. Endothelial cell loss increases over time well after the operative procedure and sometimes requires removal of the device years later. It can induce non-reversible corneal edema when the device is stopped and involve a corneal transplant. Recently, a study showed that the micro-invasive device ab interno Alcon Cypass® (device similar to XEN®) caused an endothelial cell loss that was not significant initially but significant thereafter (48 months) and not acceptable compared to conventional surgery. glaucoma. The damage was proportional to the area of the implant in the anterior chamber and led to the immediate withdrawal of the device from the market. In view of these results and the absence to date of an equivalent study for XEN®, we proposed to conduct this study in order to assess the possible cell loss compared to NPDS.
- Conditions
- Glaucoma
- Being tested
- measurement of endothelial cell density by specular microscopy
- Keywords
- endothelial cell loss, XEN® implant, filtering surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of endothelial cell density by specular microscopyDevice
During this first appointment (T0), in addition to the usual treatment, measurement of the endothelial cell density by specular microscopy will be carried out on the affected eye (basal cell density). To overcome the variability linked to the machine, three consecutive measurements will be taken; the average of the three measurements will be used.
As part of his post-operative follow-up, the patient will be reviewed at one month, one year, two years, three years, four years and five years after the operation. During these consultations and as part of the research, a new determination of the cell density (3 consecutive measurements) by specular microscopy of the operated eye and an evaluation of the position of the XEN implant will be carried out each time. ® by OCT scan for patients having undergone this surgery.
| Study group | Role | What they receive |
|---|---|---|
| specular microscopy | Experimental | The density measurement is a painless and very brief examination (less than a minute) during which the patient places his head on a chin rest while maintaining his forehead on a bar provided for this purpose while looking straight ahead. The measurements are then taken without contact with the patient's eye. Receives: Device: measurement of endothelial cell density by specular microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of the type of intervention (NPDS or XEN® placement) on endothelial cell loss 2 years after the intervention
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
Measured: 2 years
Secondary outcomes (22)
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
Measured: 1 year postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
Measured: 2 years postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
Measured: 3 years postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
Measured: 4 years postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
Measured: 5 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 10% calculated from basal cell density
Measured: 2 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 10% calculated from basal cell density
Measured: 3 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 10% calculated from basal cell density
Measured: 4 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 10% calculated from basal cell density
Measured: 5 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 20% calculated from basal cell density
Measured: 2 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 20% calculated from basal cell density
Measured: 3 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 20% calculated from basal cell density
Measured: 4 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Difference between the two eye groups in terms of percentage cell loss ≥ 20% calculated from basal cell density
Measured: 5 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 2 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 3 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 4 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 5 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 1 year postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 2 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 3 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 4 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber
Measured: 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Nov 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Why it stopped: The PI chose not to start the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves LACHKAR, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781283
- Sponsor's protocol ID
- CINEXEN
- Acronym
- CINEXEN
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma
- ClinicalTrials.gov ID
- NCT04781283
- Acronym / sponsor ID
- CINEXEN / CINEXEN
- Conditions
- Glaucoma
- Keywords
- endothelial cell loss, XEN® implant, filtering surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI chose not to start the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 4 Mar 2021 (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.
Glaucoma is a blinding optic neuropathy that affects 60 million people worldwide. Of all the types of existing glaucoma, primary open-angle glaucoma is the most common etiology. The therapeutic arsenal today includes drug lowering treatments, lasers and surgery. The most frequent glaucoma surgeries are, in France, trabeculectomy and non-perforating deep sclerectomy (NPDS). These are two filtering surgeries whose principle is to lower the intra ocular pressure (IOP) by creating an evacuation path of the aqueous humor from the anterior chamber (AC) of the eye to the space subconjunctival creating a filtration bubble (FB). These two procedures are currently considered the gold standard. They can be performed alone or at the same time as cataract surgery. The short-term complications encountered with these techniques are early hypotonia and its attendant complications (choroidal detachment, hypotonic maculopathy, hemorrhages, etc.), the most common cause of which is conjunctival leakage from the bubble. In the medium term, increases in blood pressure with deep AC testify to a scleral flap that is too tight which may require suture lysis. Finally, the problems of excessive conjunctival-Tenon healing concern 25 to 30% of those operated on and are responsible for the majority of late blood pressure increases. In the longer term, the most common complication is cataracts; the rarest, but most serious complication is infection of BF, which occurs more readily when the walls of the FB are ischemic or even perforated. It can be complicated by an extremely serious endophthalmitis. A new minimally invasive therapeutic option has been developed limiting per- and post-operative complications. Unlike traditional techniques which present an ab externo approach, the ab interno approach of the new technique proposed consists of the implantation of a tube of collagen 6 mm in length and 45 µm of light called Xen® through the AC .
Detailed description
This surgery can be performed alone or at the same time as cataract surgery. The geometry of the Xen® implant has been studied to help prevent major hypotonia. This new technique would also prevent complications related to conjunctival dissection, while being faster. The placement of a Xen® implant is now used in simple surgery or combined with cataract surgery for open-angle glaucomas, beginners to moderate, associated or not with cataract, progressive and unbalanced under local hypotonizing treatment. Since June 2017, the Xen® technique has been part of the routine in the ophthalmology department of the Paris Saint-Joseph Hospital Group (GhPSJ). The choice of technique (filtering surgery or XEN®) is left to the discretion of the surgeon. To date, no study has yet compared the efficacy and safety of this new technique compared to non-perforating deep sclerectomy: the gold standard. However, the presence of any type of anterior chamber device may be associated with endothelial cell loss even when the device is not in direct contact with the cornea. Endothelial cell loss increases over time well after the operative procedure and sometimes requires removal of the device years later. It can induce non-reversible corneal edema when the device is stopped and involve a corneal transplant. Recently, a study showed that the micro-invasive device ab interno Alcon Cypass® (device similar to XEN®) caused an endothelial cell loss that was not significant initially but significant thereafter (48 months) and not acceptable compared to conventional surgery. glaucoma. The damage was proportional to the area of the implant in the anterior chamber and led to the immediate withdrawal of the device from the market. In view of these results and the absence to date of an equivalent study for XEN®, we proposed to conduct this study in order to assess the possible cell loss compared to NPDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| specular microscopy | Experimental | Device: measurement of endothelial cell density by specular microscopyThe density measurement is a painless and very brief examination (less than a minute) during which the patient places his head on a chin rest while maintaining his forehead on a bar provided for this purpose while looking straight ahead. The measurements are then taken without contact with the patient's eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman aged ≥ 18 years
- French-speaking patient
- Patients followed for primary or secondary open-angle glaucoma in the ophthalmology department of the GhPSJ
- Patient with an indication for surgery with placement of Xen® or NDPS alone or combined with cataract surgery by phacoemulsification of the lens
- Patient affiliated to social security or, failing that, to another health insurance system
Key exclusion criteria (12 listed)
- Patient with another associated ophthalmological disease, apart from a simple cataract already operated on or operated simultaneously with NDPS or the Xen® break without complications during or after the operation
- History of filtering surgery, history of vitrectomy
- Closed-angle glaucoma
- Pseudo capsular exfoliation (connective tissue disease affecting the eye)
- Uveitic glaucoma (glaucoma related to inflammation which can itself have an effect on the cornea)
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 |
|---|---|---|
| measurement of endothelial cell density by specular microscopyDuring this first appointment (T0), in addition to the usual treatment, measurement of the endothelial cell density by specular microscopy will be carried out on the affected eye (basal cell density). To overcome the variability linked to the machine, three consecutive measurements will be taken; the average of the three measurements will be used. As part of his post-operative follow-up, the patient will be reviewed at one month, one year, two years, three years, four years and five years after the operation. During these consultations and as part of the research, a new determination of the cell density (3 consecutive measurements) by specular microscopy of the operated eye and an evaluation of the position of the XEN implant will be carried out each time. ® by OCT scan for patients having undergone this surgery. | Device | specular microscopy |
Primary outcome
To assess the impact of the type of intervention (NPDS or XEN® placement) on endothelial cell loss 2 years after the intervention
Time frame: 2 years
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density
22 secondary outcomes
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Time frame: 1 year postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Time frame: 2 years postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Time frame: 3 years postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Time frame: 4 years postoperative
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure
Time frame: 5 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Time frame: 2 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Time frame: 3 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Time frame: 4 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure
Time frame: 5 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Time frame: 2 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Time frame: 3 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Time frame: 4 years postoperative
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure
Time frame: 5 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
Time frame: 2 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
Time frame: 3 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
Time frame: 4 years postoperative
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure
Time frame: 5 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
Time frame: 1 year postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
Time frame: 2 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
Time frame: 3 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
Time frame: 4 years postoperative
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure
Time frame: 5 years postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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.
Yves LACHKAR principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
A study testing measurement of endothelial cell density by specular microscopy in people with Glaucoma, run by Fondation Hôpital Saint-Joseph.
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 12 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: withdrawn, as of the sponsor's last update on 1 Feb 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 assess the impact of the type of intervention (NPDS or XEN® placement) on endothelial cell loss 2 years after the intervention (time frame: 2 years). 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 1 Feb 2022.