Proliferative Diabetic RetinopathyPhase 4CONCEPTNCT03506750
Day Regimes of CONbercept on CytokinEs of PDR Patients Undergoing Vitrectomy - Trial (CONCEPT)
A Phase 4 study testing IVC, Blood and aqueous humor at the time of IVC and Collect blood, aqueous humor, and initial vitreous at the time of surgery. in people with Proliferative Diabetic Retinopathy and VEGF Overexpression, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Patients with proliferative diabetic retinopathy requiring surgical intervention will receive a pre-operative injection of Conbercept. Patients will be recruited into different groups according to variable time intervals (1 to 7 days) between intravitreous injection and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy, VEGF Overexpression
- What is being tested?
- IVC, Blood and aqueous humor at the time of IVC and Collect blood, aqueous humor, and initial vitreous at the time of surgery.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2017to 31 Dec 2018
- Phase
- Phase 4
- 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
- 18 years or older
- Type 1 or 2 diabetes
- PDR patients requiring surgical intervention for complications of vitreous hemorrhage or traction retinal detachment and pre-operative IVC treatment.
- women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.
Who cannot join
- previous retinal vein occlusion.
- any intraocular surgery within the previous 12 months.
- myopia of > or = to 8 diopters.
- active ocular or periocular infection
- treatment with an investigational agent for any condition 60 days prior to enrollment.
- evidence of severe cardiac disease.
Show all 9Show fewer
- clinically significant peripheral vascular disease (previous surgery, amputation, or symptoms of claudication)
- uncontrolled hypertension (treated systolic blood pressure > 155 mmHg or diastolic blood pressure > 95 mmHg)
- stroke within the preceding 12 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Zizhong Hu, Dr, 15195960100, huzizhong@njmu.edu.cn
About this study
Official title: Different Day Regimes of Preoperative CONbercept Administration on CytokinEs of Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: a Prospective Randomized Controlled Clinical Trial (CONCEPT)
Patients with proliferative diabetic retinopathy requiring surgical intervention will receive a pre-operative injection of Conbercept. Patients will be recruited into different groups according to variable time intervals (1 to 7 days) between intravitreous injection and surgery. At initial, pre-injection aqueous humor and blood sample will be collected in order to provide baseline VEGF-A, -B, placental growth factor (PIGF), and other cytokine levels. At the onset of the vitrectomy, a second aqueous humor, blood, and vitreous sample will be taken to obtain intra-operative levels of , VEGF-A, -B, PIGF, and other cytokine levels.
Read the detailed description
Proliferative diabetic retinopathy (PDR), characterized by neovascularization and fibrous proliferation, is a severe and common complication of diabetes mellitus (DM). Persistent vitreous hemorrhage (VH) caused by neovascularization and tractional retinal detachment (TRD) caused by fibrous proliferation can lead to permanent vision loss or even blindness, which are the most common indications for surgical intervention.
As neovascularization is the basal pathophysiological change of PDR and vascular endothelial growth factor (VEGF) has been acknowledged as primary angiogenesis factor, the preoperative adjunctive use of VEGF blockade is rationally proposed. The anti-VEGF drugs have been reported to be effective in bringing about regression of retinal neovascularization, shortening surgical duration, avoiding risk of iatrogenic retinal hole and secondary operation for the recurrent VH.
Conbercept (KH902) is a newly developed anti-VEGF drug and has been applied in clinic. Because of its additional binding domain of VEGFR-2, conbercept can bind to all isoforms of VEGF-A, VEGF-B, and placental growth factor (PLGF). A number of studies have presented its high affinity in the treatment of fundus diseases such as wet age-related macular degeneration (wet-AMD), macular edema secondary to retinal vein occlusion[8] and diabetic retinopathy. Also, recent randomized controlled trials have shown its protective effect of conbercept for the surgical treatment of PDR.
Although the overwhelming clinical evidence supports the anti-VEGF drugs as the preoperative adjuncts for PDR, the optimal duration between anti-VEGF injection and surgical intervention has not yet reached a consensus. Longer duration is related to higher incidence of the development or progression of TRD. It might provide clues by investigation of the pattern of cytokine changes in humor aqueous, vitreous, and blood. No studies have been done to date in patients with PDR to quantify the reduction of intravitreal VEGF-A, -B, PLGF or other cytokines levels in these patients following intravitreal Conbercept injection or to evaluate the effects of VEGF or PIGF blockade on the neovascular regression and surgical outcome in patients with extensive diabetic proliferative neovascularization.
The goal of this study is to quantify the reduction of changes of VEGF-A, -B, PLGF levels in patients receiving r pre-operative intravitreal Conbercept after variable time intervals (1, 2, 3, 4, 5, 6, 7 days).
- Being tested
- IVC, Blood and aqueous humor at the time of IVC, Collect blood, aqueous humor, and initial vitreous at the time of surgery., IVC-sham
- Keywords
- Conbercept, PLGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVCDrug
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVCProcedure or surgery
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.Procedure or surgery
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-shamProcedure or surgery
Patients with PDR will receive sham intravitreal injection of conbercept in the inferior-temporal sector 4 mm from the sclerocorneal limbus 4 days before PPV surgery.
| Study group | Role | What they receive |
|---|---|---|
| IVC-1day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 1 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-2day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 2 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-3day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 3 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-4day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 4 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-5day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 5 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-6day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 6 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-7day | Experimental | patients with proliferative diabetic retinopathy receiving IVC 7 days before surgery Receives: Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
| IVC-sham | Sham comparator | patients with proliferative diabetic retinopathy receiving sham IVC Receives: Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.; Procedure: IVC-sham |
| non-DR | Placebo comparator | patients with other retinopathy (idiopathic macular hole or epiretinal membrane) Receives: Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept).
Measured: 1-7 days
Secondary outcomes (9)
Changes of serum angiogenesis-related pro-cytokines in patients with proliferative diabetic retinopathy
Measured: 1-7 days
Changes of intraocular and serum profibrotic cytokines in patients with proliferative diabetic retinopathy post-IVC.
Measured: 1-7 days
Changes of intraocular and serum inflammatory cytokines in patients with proliferative diabetic retinopathy post-IVC.
Measured: 1-7 days
Vitreous concentration of Conbercept
Detection of Vitreous concentration of the drug of Conbercept (Conbercept is a kind of fusion protein)
Measured: 1-7 days
Effect of IVC on surgery time of surgery
surgery time of vitrectomy
Measured: Surgery day
Effect of IVC on intraoperative complication of surgery
Record the intraoperative complication: bleeding and iatrogenic retinal hole when surgically removing the proliferative membranes.
Measured: Surgery day
Effect of IVC on regression of neovascularization on vitreous fibrovascular membrane with optic coherence tomography angiography (OCTA)
OCTA monitor the changes of neovascularization on vitreous fibrovascular membrane after IVC and before surgery
Measured: 1 to 7 days
Effect of IVC on postoperative visual acuity
Best-corrected visual acuity postoperatively
Measured: 1 to12 months
Effect of IVC on postoperative complications
Record number of patient with vitreous re-bleeding and iris neovascularization postoperatively.
Measured: 1 to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start3 Jun 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zizhong Hu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Qinghuai Liu, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506750
- Sponsor's protocol ID
- CONCEPT
- Acronym
- CONCEPT
- Status last verified
- Apr 2018
- First submitted
- 9 Mar 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen DY, Sun NH, Chen X, Gong JJ, Yuan ST, Hu ZZ, Lu NN, Korbelin J, Fukunaga K, Liu QH, Lu YM, Han F. Endothelium-derived semaphorin 3G attenuates ischemic retinopathy by coordinating beta-catenin-dependent vascular remodeling. J Clin Invest. 2021 Feb 15;131(4):e135296. doi: 10.1172/JCI135296.
PubMed 33586674
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Day Regimes of Preoperative CONbercept Administration on CytokinEs of Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: a Prospective Randomized Controlled Clinical Trial (CONCEPT)
- ClinicalTrials.gov ID
- NCT03506750
- Acronym / sponsor ID
- CONCEPT / CONCEPT
- Keywords
- Conbercept, PLGF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 24 Apr 2018 (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.
Patients with proliferative diabetic retinopathy requiring surgical intervention will receive a pre-operative injection of Conbercept. Patients will be recruited into different groups according to variable time intervals (1 to 7 days) between intravitreous injection and surgery. At initial, pre-injection aqueous humor and blood sample will be collected in order to provide baseline VEGF-A, -B, placental growth factor (PIGF), and other cytokine levels. At the onset of the vitrectomy, a second aqueous humor, blood, and vitreous sample will be taken to obtain intra-operative levels of , VEGF-A, -B, PIGF, and other cytokine levels.
Detailed description
Proliferative diabetic retinopathy (PDR), characterized by neovascularization and fibrous proliferation, is a severe and common complication of diabetes mellitus (DM). Persistent vitreous hemorrhage (VH) caused by neovascularization and tractional retinal detachment (TRD) caused by fibrous proliferation can lead to permanent vision loss or even blindness, which are the most common indications for surgical intervention.
As neovascularization is the basal pathophysiological change of PDR and vascular endothelial growth factor (VEGF) has been acknowledged as primary angiogenesis factor, the preoperative adjunctive use of VEGF blockade is rationally proposed. The anti-VEGF drugs have been reported to be effective in bringing about regression of retinal neovascularization, shortening surgical duration, avoiding risk of iatrogenic retinal hole and secondary operation for the recurrent VH.
Conbercept (KH902) is a newly developed anti-VEGF drug and has been applied in clinic. Because of its additional binding domain of VEGFR-2, conbercept can bind to all isoforms of VEGF-A, VEGF-B, and placental growth factor (PLGF). A number of studies have presented its high affinity in the treatment of fundus diseases such as wet age-related macular degeneration (wet-AMD), macular edema secondary to retinal vein occlusion[8] and diabetic retinopathy. Also, recent randomized controlled trials have shown its protective effect of conbercept for the surgical treatment of PDR.
Although the overwhelming clinical evidence supports the anti-VEGF drugs as the preoperative adjuncts for PDR, the optimal duration between anti-VEGF injection and surgical intervention has not yet reached a consensus. Longer duration is related to higher incidence of the development or progression of TRD. It might provide clues by investigation of the pattern of cytokine changes in humor aqueous, vitreous, and blood. No studies have been done to date in patients with PDR to quantify the reduction of intravitreal VEGF-A, -B, PLGF or other cytokines levels in these patients following intravitreal Conbercept injection or to evaluate the effects of VEGF or PIGF blockade on the neovascular regression and surgical outcome in patients with extensive diabetic proliferative neovascularization.
The goal of this study is to quantify the reduction of changes of VEGF-A, -B, PLGF levels in patients receiving r pre-operative intravitreal Conbercept after variable time intervals (1, 2, 3, 4, 5, 6, 7 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| IVC-1day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 1 days before surgery |
| IVC-2day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 2 days before surgery |
| IVC-3day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 3 days before surgery |
| IVC-4day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 4 days before surgery |
| IVC-5day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 5 days before surgery |
| IVC-6day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 6 days before surgery |
| IVC-7day | Experimental | Drug: IVC, Procedure: Blood and aqueous humor at the time of IVC, Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with proliferative diabetic retinopathy receiving IVC 7 days before surgery |
| IVC-sham | Sham comparator | Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery., Procedure: IVC-shampatients with proliferative diabetic retinopathy receiving sham IVC |
| non-DR | Placebo comparator | Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.patients with other retinopathy (idiopathic macular hole or epiretinal membrane) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Type 1 or 2 diabetes
- PDR patients requiring surgical intervention for complications of vitreous hemorrhage or traction retinal detachment and pre-operative IVC treatment.
- women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.
Key exclusion criteria (9 listed)
- previous retinal vein occlusion.
- any intraocular surgery within the previous 12 months.
- myopia of > or = to 8 diopters.
- active ocular or periocular infection
- treatment with an investigational agent for any condition 60 days prior to enrollment.
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 |
|---|---|---|
| IVCPatients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery. | Drug | IVC-1day, IVC-2day, IVC-3day, IVC-4day, IVC-5day, IVC-6day, IVC-7day |
| Blood and aqueous humor at the time of IVCInitial blood and aqueous humor will be harvested at the time of IVC. | Procedure or surgery | IVC-1day, IVC-2day, IVC-3day, IVC-4day, IVC-5day, IVC-6day, IVC-7day |
| Collect blood, aqueous humor, and initial vitreous at the time of surgery.Blood, aqueous humor, and vitreous will be collected at the time of surgery. | Procedure or surgery | IVC-1day, IVC-2day, IVC-3day, IVC-4day, IVC-5day, IVC-6day, IVC-7day, IVC-sham, non-DR |
| IVC-shamPatients with PDR will receive sham intravitreal injection of conbercept in the inferior-temporal sector 4 mm from the sclerocorneal limbus 4 days before PPV surgery. | Procedure or surgery | IVC-sham |
Primary outcome
Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept).
Time frame: 1-7 days
9 secondary outcomes
Changes of serum angiogenesis-related pro-cytokines in patients with proliferative diabetic retinopathy
Time frame: 1-7 days
Changes of intraocular and serum profibrotic cytokines in patients with proliferative diabetic retinopathy post-IVC.
Time frame: 1-7 days
Changes of intraocular and serum inflammatory cytokines in patients with proliferative diabetic retinopathy post-IVC.
Time frame: 1-7 days
Vitreous concentration of Conbercept
Time frame: 1-7 days
Effect of IVC on surgery time of surgery
Time frame: Surgery day
Effect of IVC on intraoperative complication of surgery
Time frame: Surgery day
Effect of IVC on regression of neovascularization on vitreous fibrovascular membrane with optic coherence tomography angiography (OCTA)
Time frame: 1 to 7 days
Effect of IVC on postoperative visual acuity
Time frame: 1 to12 months
Effect of IVC on postoperative complications
Time frame: 1 to12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 33586674Chen DY, Sun NH, Chen X, Gong JJ, Yuan ST, Hu ZZ, Lu NN, Korbelin J, Fukunaga K, Liu QH, Lu YM, Han F. Endothelium-derived semaphorin 3G attenuates ischemic retinopathy by coordinating beta-catenin-dependent vascular remodeling. J Clin Invest. 2021 Feb 15;131(4):e135296. doi: 10.1172/JCI135296.
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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.
Qinghuai Liu study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IVC, Blood and aqueous humor at the time of IVC and Collect blood, aqueous humor, and initial vitreous at the time of surgery. in people with Proliferative Diabetic Retinopathy and VEGF Overexpression, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Apr 2018. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zizhong Hu, Dr (15195960100, huzizhong@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept). (time frame: 1-7 days). 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 NCT03506750, which also lists 1 linked publication.
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 24 Apr 2018.