Macular EdemaDRAKONCT02850263

A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema

An observational study of Macular Edema, run by Bayer at 1 site in United Kingdom.

Completed

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

Trial summary

Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Edema
What is being tested?: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) and Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
How many people: 750 participants
Where: 1 siteUnited Kingdom
Study dates: 5 Jul 2016to 23 Nov 2020
Phase: Observational
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

Study population: Female and male patients with a diagnosis of diabetic macular oedema with central involvement will be enrolled after the decision for treatment with intravitreal aflibercept has been made.

Who may be able to join

Patients aged 18 years or older.
Patients diagnosed with type 1 or 2 diabetes mellitus.
Patients diagnosed with DMO with central involvement (defined as the area of the centre subfield of OCT) treated with intravitreal aflibercept (in accordance with routine practice).
Patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion.
Patients must provide written informed consent.

Who cannot join

Patients under the age of 18.
Patients with contraindications as listed in the SmPC for intravitreal aflibercept.
Patients with pre-planned cataract surgery during the observational period.
Patients previously treated with intravitreal anti-VEGF within 28 days.
Patients currently or previously treated with systemic anti-VEGF.
Patients previously treated with intravitreal fluocinolone acetonide steroid.
Patients participating in an investigational programme with interventions outside of routine clinical practice.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Multiple Locations

Other trials in United Kingdom

About this study

Official title: An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)

Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.

The main objectives of this observational cohort field study are to evaluate effectiveness of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine clinical practice in the United Kingdom.

Conditions: Macular Edema
Being tested: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321), Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Keywords: Diabetic Retinopathy, Diabetic Macular Oedema, Diabetic Macular Edema, Aflibercept
Medical subject headings: Macular Edema, Diabetic Retinopathy

What participants receive

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

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)Drug
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)Drug
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.

Study groups in NCT02850263
Study group	Role	What they receive
Cohort 1 / Anti-VEGF treatment naïve patients		Anti-VEGF treatment of naïve patients (who have not received any previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the United Kingdom. Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Cohort 2 / Anti-VEGF treatment non-naïve patients		Anti-VEGF treatment of non-naïve patients (who have received previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK. Receives: Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Cohort 3 / Total study population		Anti-VEGF treatment naïve patients and anti-VEGF treatment non-naïve patients with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK. Receives: Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)

What is being measured

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

Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
BCVA (Best Corrected Visual Acuity): process to measure with the help of a retinoscope, auto-refractor or phoropter how much power is needed to bring the eye to normal, perfectly focused vision) when performed in addition to that at baseline and 12 months. ETDRS Chart: charts imprinted with lines of letters decreasing in size from largest on top to smallest on the bottom to determine visual acuity.
Measured: Baseline and 12 months
Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
Measured: Baseline and 12 months

Secondary outcomes (21)

Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
Measured: Baseline and 24 months
Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
Measured: Baseline and 24 months
Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept
Measured: Baseline, 12 and 24 months
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept differentiated by BCVA baseline characteristics
Measured: Baseline, 12 and 24 months
Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics
Measured: Baseline, 12 and 24 months
Proportion (%) of patients discontinuing intravitreal aflibercept treatment
Measured: Baseline, 12 and 24 months
Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment
Measured: Baseline
The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment
Measured: Baseline
Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss
Measured: Baseline, 12 and 24 months
Proportion (%) of sites that adhere to their stated treatment protocol
Measured: 12 and 24 months
Change in QoL score measured by NEI VFQ-25
Measured: Baseline, 12 and 24 months
Change in macular volume
Measured: Baseline, 12 and 24 months
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters
Measured: Baseline, 12 and 24 months
Change in non-refracted visual acuity (VA).for the fellow eye
Measured: Baseline, 12 and 24 months
Number of DMO treatments required for the fellow eye
Measured: Baseline, 12 and 24 months
Number of visits performed (resources) to assess the fellow eye
Measured: Baseline, 12 and 24 months
Number of clinical procedures performed (resources) to assess the fellow eye
Measured: Baseline, 12 and 24 months
Number of adverse events as a measure of safety and tolerability
Measured: 24 months
Reason for discontinuation of intravitreal aflibercept treatment
Measured: Baseline, 12 and 24 months
Change in Central Subfield Thickness (CST) of the fellow eye
Measured: Baseline, 12 and 24 months
Type of DMO treatments required for the fellow eye
Measured: Baseline, 12 and 24 months

Timeline

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

5 Jul 201623 Nov 2020

First posted29 Jul 2016 (estimated)
Study start5 Jul 2016
Primary completion30 May 2019
Study completion23 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Macular EdemaStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
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: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02850263
Sponsor's protocol ID: 18058
Acronym: DRAKO
Status last verified: Oct 2021
First submitted: 19 May 2016
Last updated: 2 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J; DRAKO study group. Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes. Eye (Lond). 2022 Jan;36(1):64-71. doi: 10.1038/s41433-021-01624-9. Epub 2021 Jul 9.
PubMed 34244670
Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J. Evaluation of care with intravitreal aflibercept treatment for UK patients with diabetic macular oedema: DRAKO study 24-month real-world outcomes. Eye (Lond). 2023 Sep;37(13):2753-2760. doi: 10.1038/s41433-023-02409-y. Epub 2023 Mar 20.
PubMed 36941402

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?

See locations

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Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
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All Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)
ClinicalTrials.gov ID: NCT02850263
Acronym / sponsor ID: DRAKO / 18058
Conditions: Macular Edema
Keywords: Diabetic Retinopathy, Diabetic Macular Oedema, Diabetic Macular Edema, Aflibercept
Study type: Observational
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 5 Jul 2016 (actual)
Primary completion: 30 May 2019 (actual)
Study completion: 23 Nov 2020 (actual)
First posted: 29 Jul 2016 (estimated)
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.

Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.

Study design

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

Arm	Type	Receives
Cohort 1 / Anti-VEGF treatment naïve patients	–	Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Anti-VEGF treatment of naïve patients (who have not received any previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the United Kingdom.
Cohort 2 / Anti-VEGF treatment non-naïve patients	–	Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)Anti-VEGF treatment of non-naïve patients (who have received previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Cohort 3 / Total study population	–	Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)Anti-VEGF treatment naïve patients and anti-VEGF treatment non-naïve patients with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Female and male patients with a diagnosis of diabetic macular oedema with central involvement will be enrolled after the decision for treatment with intravitreal aflibercept has been made.

Key inclusion criteria (5 listed)

Patients aged 18 years or older.
Patients diagnosed with type 1 or 2 diabetes mellitus.
Patients diagnosed with DMO with central involvement (defined as the area of the centre subfield of OCT) treated with intravitreal aflibercept (in accordance with routine practice).
Patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion.
Patients must provide written informed consent.

Key exclusion criteria (7 listed)

Patients under the age of 18.
Patients with contraindications as listed in the SmPC for intravitreal aflibercept.
Patients with pre-planned cataract surgery during the observational period.
Patients previously treated with intravitreal anti-VEGF within 28 days.
Patients currently or previously treated with systemic anti-VEGF.

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
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.	Drug	Cohort 1 / Anti-VEGF treatment naïve patients
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.	Drug	Cohort 2 / Anti-VEGF treatment non-naïve patients
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.	Drug	Cohort 3 / Total study population

Primary outcome

Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
Time frame: Baseline and 12 months
BCVA (Best Corrected Visual Acuity): process to measure with the help of a retinoscope, auto-refractor or phoropter how much power is needed to bring the eye to normal, perfectly focused vision) when performed in addition to that at baseline and 12 months. ETDRS Chart: charts imprinted with lines of letters decreasing in size from largest on top to smallest on the bottom to determine visual acuity.
Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
Time frame: Baseline and 12 months

21 secondary outcomes

Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
Time frame: Baseline and 24 months
Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
Time frame: Baseline and 24 months
Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept
Time frame: Baseline, 12 and 24 months
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept differentiated by BCVA baseline characteristics
Time frame: Baseline, 12 and 24 months
Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics
Time frame: Baseline, 12 and 24 months
Proportion (%) of patients discontinuing intravitreal aflibercept treatment
Time frame: Baseline, 12 and 24 months
Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment
Time frame: Baseline
The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment
Time frame: Baseline
Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss
Time frame: Baseline, 12 and 24 months
Proportion (%) of sites that adhere to their stated treatment protocol
Time frame: 12 and 24 months
Change in QoL score measured by NEI VFQ-25
Time frame: Baseline, 12 and 24 months
Change in macular volume
Time frame: Baseline, 12 and 24 months
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters
Time frame: Baseline, 12 and 24 months
Change in non-refracted visual acuity (VA).for the fellow eye
Time frame: Baseline, 12 and 24 months
Number of DMO treatments required for the fellow eye
Time frame: Baseline, 12 and 24 months
Number of visits performed (resources) to assess the fellow eye
Time frame: Baseline, 12 and 24 months
Number of clinical procedures performed (resources) to assess the fellow eye
Time frame: Baseline, 12 and 24 months
Number of adverse events as a measure of safety and tolerability
Time frame: 24 months
Reason for discontinuation of intravitreal aflibercept treatment
Time frame: Baseline, 12 and 24 months
Change in Central Subfield Thickness (CST) of the fellow eye
Time frame: Baseline, 12 and 24 months
Type of DMO treatments required for the fellow eye
Time frame: Baseline, 12 and 24 months

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 2 Nov 2021.
Results publication: PubMed 34244670Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J; DRAKO study group. Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes. Eye (Lond). 2022 Jan;36(1):64-71. doi: 10.1038/s41433-021-01624-9. Epub 2021 Jul 9.
Derived from this study: PubMed 36941402Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J. Evaluation of care with intravitreal aflibercept treatment for UK patients with diabetic macular oedema: DRAKO study 24-month real-world outcomes. Eye (Lond). 2023 Sep;37(13):2753-2760. doi: 10.1038/s41433-023-02409-y. Epub 2023 Mar 20.
Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Related trials for Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
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Not yet 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.

Bayer Study Director study director

Bayer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Edema, run by Bayer at 1 site in United Kingdom.

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 5 inclusion and 7 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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 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?

Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept (time frame: Baseline and 12 months). The study lists 2 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 NCT02850263, 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 2 Nov 2021.