Center-involved Diabetic Macular EdemaPhase 3NCT04288232
Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan
A Phase 3 study testing Aflibercept Injection [Eylea] in people with Center-involved Diabetic Macular Edema, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
Phase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Center-involved Diabetic Macular Edema
- What is being tested?
- Aflibercept Injection [Eylea]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2015to 16 Nov 2017
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 20 years old with type 1 or 2 diabetes mellitus
- Subjects with DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield of optical coherence tomography [OCT]) in the study eye
- Retinal thickness as assessed by OCT above (>) 300 um in the study eye
- BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
- Would be able to comply with clinic visits and study-related procedures
- Would be able to provide a signed informed consent form (ICF)
Who cannot join
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- History of vitreoretinal surgery and/or including scleral buckling in the study eye
- Laser photocoagulation (pan-retinal or macular) in the study eye within 90 days of Day 1
- Against the background of a relevant number of previous macular laser treatments the investigator's point of view was that the subjects had no potential to benefit from laser treatments (e.g., if too many laser treatments were applied in the past)
- Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
- Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
Show all 39Show fewer
- High risk proliferative diabetic retinopathy (PDR) in the study eye upon physician's discretion
- High risk = the presence of any of the following:
- Vitreous hemorrhage
- New vessels on the disk >1/3 disk diameter
- New vessels elsewhere >1/2 disk diameter
- History of idiopathic or autoimmune uveitis in the study eye
- Cataract surgery within 90 days before Day 1 in the study eye
- Aphakia in the study eye
- Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 30 days before Day 1
- Any other intraocular surgery within 90 days of Day 1 in the study eye
- Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
- Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
- Pre-retinal fibrosis involving the macula in the study eye
- Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
- Ocular inflammation including trace or above in the study eye
- Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
- Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
- High myopia (≤ -6.0 diopters or axial length of ≥26.5 mm) prior to any possible refractive or cataract surgery
- Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
- Only 1 functional eye even if that eye was otherwise eligible for the study
- Ocular media of insufficient quality to obtain fundus and OCT images
- Current treatment for a serious systemic infection
- Administration of systemic anti-angiogenic agents within 180 days before Day 1
- Uncontrolled diabetes mellitus, as defined by Hemoglobin A1c; (glycosylated hemoglobin) (HbA1c)>10%.
- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg while subject was sitting)
- History of either cerebral vascular accident and/or myocardial infarction within 180 days prior to Day 1
- Renal failure requiring dialysis or renal transplant
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or rendered the subject at high risk for treatment complications
- Pregnant or breast-feeding women
- Sexually active men or women of childbearing potential who were unwilling to practice adequate contraception during the study were excluded (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or jelly).
- Allergy to fluorescein
- Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device
About this study
Official title: A Multicenter, Open-label, Prospective, Interventional Study to Assess the Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan
Phase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52.
- Conditions
- Center-involved Diabetic Macular Edema
- Being tested
- Aflibercept Injection [Eylea]
- Keywords
- anti-VEGF, intravitreal aflibercept, diabetic macular edema, Treat-and-Extend regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Injection [Eylea]Drug
Intravitreal aflibercept Injection 2.0mg/0.05 ml
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal aflibercept | Experimental | Intravitreal injection of aflibercept 2.0mg/0.05 ml Aflibercept was administered with 5 monthly loadings followed by treat-and-extend with a 4-week interval increment/decrement with maxima cap at 12 weeks to visual/anatomic stability. Receives: Drug: Aflibercept Injection [Eylea] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of best corrected visual acuity (BCVA) from baseline to week 52
BCVA is measured by ETDRS chart
Measured: baseline to week 52
Secondary outcomes (5)
Mean change in central subfoveal thickness (CST) from baseline to week 52.
Central subfoveal thickness (CST) as assessed by OCT
Measured: baseline to week 52
Mean/medium number of injection from baseline to week 52
Mean/medium number of intravitreal aflibercept injection from baseline to week 52
Measured: baseline to week 52
Proportion of subjects who gained > 15 ETDRS letters from baseline to week 52
BCVA is measured by ETDRS chart
Measured: baseline to week 52
Proportion of subjects with > 2-step improvement in DRSS from baseline to week 52
DR level as assessed by diabetic retinopathy severity score (DRSS)
Measured: baseline to week 52
Proportion of subjects demonstrating retina dry at week 20 and week 52
Retina dry as assessed by OCT
Measured: week 20 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start31 Aug 2015
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Center-involved Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Kaohsiung Veterans General Hospital., National Taiwan University Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Shih-Jen Chen, MD, PhD, Principal investigator, Department of Ophthalmology, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288232
- Sponsor's protocol ID
- 17683
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
PubMed 6367725Moss SE, Klein R, Klein BE. Ten-year incidence of visual loss in a diabetic population. Ophthalmology. 1994 Jun;101(6):1061-70. doi: 10.1016/s0161-6420(94)31217-6.
PubMed 8008348Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.
PubMed 9627648Zhang X, Saaddine JB, Chou CF, Cotch MF, Cheng YJ, Geiss LS, Gregg EW, Albright AL, Klein BE, Klein R. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA. 2010 Aug 11;304(6):649-56. doi: 10.1001/jama.2010.1111.
PubMed 20699456Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
PubMed 20335585Wang FH, Liang YB, Zhang F, Wang JJ, Wei WB, Tao QS, Sun LP, Friedman DS, Wang NL, Wong TY. Prevalence of diabetic retinopathy in rural China: the Handan Eye Study. Ophthalmology. 2009 Mar;116(3):461-7. doi: 10.1016/j.ophtha.2008.10.003. Epub 2009 Jan 24.
PubMed 19168222Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.
PubMed 9034784Ferrara N. VEGF: an update on biological and therapeutic aspects. Curr Opin Biotechnol. 2000 Dec;11(6):617-24. doi: 10.1016/s0958-1669(00)00153-1.
PubMed 11102799Nguyen QD, Tatlipinar S, Shah SM, Haller JA, Quinlan E, Sung J, Zimmer-Galler I, Do DV, Campochiaro PA. Vascular endothelial growth factor is a critical stimulus for diabetic macular edema. Am J Ophthalmol. 2006 Dec;142(6):961-9. doi: 10.1016/j.ajo.2006.06.068. Epub 2006 Aug 2.
PubMed 17046701Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001.
PubMed 19171208Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005656. doi: 10.1002/14651858.CD005656.pub2.
PubMed 18254088El Sanharawi M, Kowalczuk L, Touchard E, Omri S, de Kozak Y, Behar-Cohen F. Protein delivery for retinal diseases: from basic considerations to clinical applications. Prog Retin Eye Res. 2010 Nov;29(6):443-65. doi: 10.1016/j.preteyeres.2010.04.001. Epub 2010 Apr 14.
PubMed 20398784Angelousi A, Larger E. Anaemia, a common but often unrecognized risk in diabetic patients: a review. Diabetes Metab. 2015 Feb;41(1):18-27. doi: 10.1016/j.diabet.2014.06.001. Epub 2014 Jul 17.
PubMed 25043174Buyukkaya E, Karakas MF, Karakas E, Akcay AB, Tanboga IH, Kurt M, Sen N. Correlation of neutrophil to lymphocyte ratio with the presence and severity of metabolic syndrome. Clin Appl Thromb Hemost. 2014 Mar;20(2):159-63. doi: 10.1177/1076029612459675. Epub 2012 Sep 18.
PubMed 22992349Sefil F, Ulutas KT, Dokuyucu R, Sumbul AT, Yengil E, Yagiz AE, Yula E, Ustun I, Gokce C. Investigation of neutrophil lymphocyte ratio and blood glucose regulation in patients with type 2 diabetes mellitus. J Int Med Res. 2014 Apr;42(2):581-8. doi: 10.1177/0300060513516944. Epub 2014 Feb 24.
PubMed 24567354
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Prospective, Interventional Study to Assess the Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan
- ClinicalTrials.gov ID
- NCT04288232
- Acronym / sponsor ID
- 17683
- Conditions
- Center-involved Diabetic Macular Edema
- Keywords
- anti-VEGF, intravitreal aflibercept, diabetic macular edema, Treat-and-Extend regimen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Kaohsiung Veterans General Hospital., National Taiwan University Hospital, Chang Gung Memorial Hospital
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 28 Feb 2020 (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.
Phase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal aflibercept | Experimental | Drug: Aflibercept Injection [Eylea]Intravitreal injection of aflibercept 2.0mg/0.05 ml Aflibercept was administered with 5 monthly loadings followed by treat-and-extend with a 4-week interval increment/decrement with maxima cap at 12 weeks to visual/anatomic stability. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 20 years old with type 1 or 2 diabetes mellitus
- Subjects with DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield of optical coherence tomography [OCT]) in the study eye
- Retinal thickness as assessed by OCT above (>) 300 um in the study eye
- BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
- Would be able to comply with clinic visits and study-related procedures
Key exclusion criteria (39 listed)
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- History of vitreoretinal surgery and/or including scleral buckling in the study eye
- Laser photocoagulation (pan-retinal or macular) in the study eye within 90 days of Day 1
- Against the background of a relevant number of previous macular laser treatments the investigator's point of view was that the subjects had no potential to benefit from laser treatments (e.g., if too many laser treatments were applied in the past)
- Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
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 |
|---|---|---|
| Aflibercept Injection [Eylea]Intravitreal aflibercept Injection 2.0mg/0.05 ml | Drug | Intravitreal aflibercept |
Primary outcome
Mean change of best corrected visual acuity (BCVA) from baseline to week 52
Time frame: baseline to week 52
BCVA is measured by ETDRS chart
5 secondary outcomes
Mean change in central subfoveal thickness (CST) from baseline to week 52.
Time frame: baseline to week 52
Mean/medium number of injection from baseline to week 52
Time frame: baseline to week 52
Proportion of subjects who gained > 15 ETDRS letters from baseline to week 52
Time frame: baseline to week 52
Proportion of subjects with > 2-step improvement in DRSS from baseline to week 52
Time frame: baseline to week 52
Proportion of subjects demonstrating retina dry at week 20 and week 52
Time frame: week 20 and week 52
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 28 Feb 2020.
- Background: PubMed 6367725Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
- Background: PubMed 8008348Moss SE, Klein R, Klein BE. Ten-year incidence of visual loss in a diabetic population. Ophthalmology. 1994 Jun;101(6):1061-70. doi: 10.1016/s0161-6420(94)31217-6.
- Background: PubMed 9627648Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.
- Background: PubMed 20699456Zhang X, Saaddine JB, Chou CF, Cotch MF, Cheng YJ, Geiss LS, Gregg EW, Albright AL, Klein BE, Klein R. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA. 2010 Aug 11;304(6):649-56. doi: 10.1001/jama.2010.1111.
- Background: PubMed 20335585Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
- Background: PubMed 19168222Wang FH, Liang YB, Zhang F, Wang JJ, Wei WB, Tao QS, Sun LP, Friedman DS, Wang NL, Wong TY. Prevalence of diabetic retinopathy in rural China: the Handan Eye Study. Ophthalmology. 2009 Mar;116(3):461-7. doi: 10.1016/j.ophtha.2008.10.003. Epub 2009 Jan 24.
- Background: PubMed 9034784Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.
- Background: PubMed 11102799Ferrara N. VEGF: an update on biological and therapeutic aspects. Curr Opin Biotechnol. 2000 Dec;11(6):617-24. doi: 10.1016/s0958-1669(00)00153-1.
- Background: PubMed 17046701Nguyen QD, Tatlipinar S, Shah SM, Haller JA, Quinlan E, Sung J, Zimmer-Galler I, Do DV, Campochiaro PA. Vascular endothelial growth factor is a critical stimulus for diabetic macular edema. Am J Ophthalmol. 2006 Dec;142(6):961-9. doi: 10.1016/j.ajo.2006.06.068. Epub 2006 Aug 2.
- Background: PubMed 19171208Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001.
- Background: PubMed 18254088Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005656. doi: 10.1002/14651858.CD005656.pub2.
- Background: PubMed 20398784El Sanharawi M, Kowalczuk L, Touchard E, Omri S, de Kozak Y, Behar-Cohen F. Protein delivery for retinal diseases: from basic considerations to clinical applications. Prog Retin Eye Res. 2010 Nov;29(6):443-65. doi: 10.1016/j.preteyeres.2010.04.001. Epub 2010 Apr 14.
- Individual participant dataSharing planned: No
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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.
Shih-Jen Chen, MD, PhD principal investigator
Department of Ophthalmology, Taipei Veterans General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aflibercept Injection [Eylea] in people with Center-involved Diabetic Macular Edema, run by Taipei Veterans General Hospital, Taiwan.
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 39 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 28 Feb 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean change of best corrected visual acuity (BCVA) from baseline to week 52 (time frame: baseline to week 52). 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 NCT04288232, which also lists 21 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 28 Feb 2020.