Myopic Choroidal NeovascularizationNCT07402629
Deep Learning-Based OCTA Quantification and Modeling for Predicting Long-Term Anti-VEGF Efficacy in mCNV
An observational study of Myopic Choroidal Neovascularization, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Myopic choroidal neovascularization (mCNV) is one of the sight-threatening complications secondary to pathological myopia. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is its first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myopic Choroidal Neovascularization
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with initially diagnosed, treatment-naïve active mCNV who are scheduled to undergo intravitreal anti-VEGF injection.
Who may be able to join
- Myopic spherical equivalent greater than -6.0 diopters and/or axial length > 26.5 mm.
- Patients presenting with myopic fundus changes, as defined by the International Photographic Classification System for Myopic Maculopathy.
- Completion of a comprehensive ophthalmic examination at initial diagnosis, including Best Corrected Visual Acuity , slit-lamp examination, dilated fundus examination, intraocular pressure measurement, refractometry, axial length measurement, color fundus photography, Optical Coherence Tomography, OCT Angiography, and Fundus Fluorescein Angiography.
- Patients with active mCNV at initial diagnosis who are treatment-naïve.
- Final inclusion of all images required confirmation by two retinal specialists. Images with discrepant assessments were adjudicated by a senior researcher to reach a final decision.
Who cannot join
- Patients with choroidal neovascularization (CNV) due to causes other than myopia, such as age-related macular degeneration, adult-onset foveomacular vitelliform dystrophy, multifocal choroiditis, punctate inner choroidopathy, or retinoschisis.
- Poor-quality OCTA images, for example, those containing projection artifacts from overlying vessels at the mCNV lesion site, or excessively dark images dominated by thick outer choroidal vessels.
- Patients with a history of intraocular surgery, such as prior pars plana vitrectomy.
- Subjects who developed any of the above conditions during the follow-up period or who requested to withdraw from the study were removed from the experimental cohort.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Myopic choroidal neovascularization (mCNV) is one of the sight-threatening complications secondary to pathological myopia. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is its first-line therapy. However, mCNV is prone to recurrence and long-term visual decline, and there is currently no definitive method for predicting long-term prognosis. This project aims to conduct a long-term follow-up and multi-dimensional quantitative analysis of mCNV using optical coherence tomography angiography (OCTA) images. It seeks to evaluate long-term prognostic indicators, such as recurrence and long-term visual acuity, following anti-VEGF therapy for mCNV, and to construct a deep learning (DL) prediction model for anti-VEGF efficacy based on multi-modal clinical data, ultimately enabling treatment personalization.
First, deep learning technology will be utilized to segment and quantitatively analyze mCNV in OCTA images, obtaining multi-dimensional quantitative parameters. These include OCTA-based The mCNV area and vessel junction(VJ). Patients will be followed up regularly for two years post-treatment, monitoring the number of injections, mCNV recurrence, OCT and OCTA quantitative parameters, fundus chorioretinal atrophy lesions, and visual acuity status. A multi-modal DL prediction model will be constructed, primarily based on the multi-dimensional quantitative characteristics of mCNV from OCTA images. This model will aim to identify sensitive indicators for predicting best-corrected visual acuity and recurrence after anti-VEGF therapy for mCNV and to clarify the relationship between therapeutic efficacy, baseline lesion status, and treatment regimen selection.
This research will open new avenues for clinically assessing the long-term efficacy of anti-VEGF therapy for mCNV, significantly improve the efficiency and accuracy of efficacy evaluation, and provide a critical reference for personalizing anti-VEGF treatment plans, holding substantial clinical significance.
- Conditions
- Myopic Choroidal Neovascularization
- Being tested
- No interventions beyond routine medical care
- Keywords
- Deep learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions beyond routine medical careOther
No interventions beyond routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naïve patients with active mCNV at initial diagnosis, scheduled for intravitreal anti-VEGF | Not described Receives: Other: No interventions beyond routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity at 24 Months
This outcome evaluates the change in best-corrected visual acuity (BCVA) from baseline to 24 months in eyes with myopic choroidal neovascularization receiving intravitreal anti-vascular endothelial growth factor treatment as part of routine clinical care. BCVA reflects functional visual outcome and is measured at each visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under standardized testing conditions. BCVA values are recorded as ETDRS letter scores, and the primary assessment is the within-eye change from baseline to the 24-month follow-up visit.
Measured: Baseline to 24 months
Number of Recurrence Events During 24-Month Follow-up
This outcome assesses disease activity by quantifying the number of recurrence events during the 24-month follow-up period in eyes with myopic choroidal neovascularization treated with intravitreal anti-vascular endothelial growth factor therapy. Recurrence is defined as the reappearance of active myopic choroidal neovascularization following an initial treatment response, as determined by clinical examination and imaging findings, including evidence of lesion activity that necessitates additional anti-vascular endothelial growth factor treatment.
Measured: Baseline to 24 months
Secondary outcomes (2)
Change in Myopic Choroidal Neovascularization Area at 24 Months
This outcome evaluates anatomical changes of the neovascular lesion by assessing the change in myopic choroidal neovascularization (mCNV) area from baseline to 24 months using optical coherence tomography angiography (OCTA). mCNV area is defined as the total en face area of the neovascular lesion identified on OCTA images. Measurements are obtained at baseline and follow-up visits to assess longitudinal changes in lesion size associated with anti-vascular endothelial growth factor treatment during the 24-month observation period.
Measured: Baseline to 24 months
Change In Number of Vessel Junctions at 24 Months
This outcome assesses microvascular structural characteristics of the myopic choroidal neovascularization lesion by evaluating changes in the number of vessel junctions from baseline to 24 months using optical coherence tomography angiography (OCTA). Vessel junctions are defined as branching or connection points within the neovascular network visible on OCTA images. Changes in vessel junctions over time are used to describe morphological remodeling of the neovascular complex following intravitreal anti-vascular endothelial growth factor treatment during the follow-up period.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Myopic Choroidal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402629
- Sponsor's protocol ID
- 2025-1039
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang HS, Kim JG, Kim JT, Joe SG. Prognostic factors of eyes with naive subfoveal myopic choroidal neovascularization after intravitreal bevacizumab. Am J Ophthalmol. 2013 Dec;156(6):1201-1210.e2. doi: 10.1016/j.ajo.2013.08.002. Epub 2013 Sep 25.
PubMed 24075429Wang Y, Hu Z, Zhu T, Su Z, Fang X, Lin J, Chen Z, Su Z, Ye P, Ma J, Zhang L, Li J, Feng L, Sun CB, Zhang Z, Shentu X. Optical Coherence Tomography Angiography-Based Quantitative Assessment of Morphologic Changes in Active Myopic Choroidal Neovascularization During Anti-vascular Endothelial Growth Factor Therapy. Front Med (Lausanne). 2021 May 7;8:657772. doi: 10.3389/fmed.2021.657772. eCollection 2021.
PubMed 34026789Hosoda Y, Miyata M, Uji A, Ooto S, Yamashiro K, Tamura H, Oishi A, Ueda-Arakawa N, Miyake M, Hata M, Muraoka Y, Takahashi A, Tsujikawa A. Novel Predictors of Visual Outcome in Anti-VEGF Therapy for Myopic Choroidal Neovascularization Derived Using OCT Angiography. Ophthalmol Retina. 2018 Nov;2(11):1118-1124. doi: 10.1016/j.oret.2018.04.011. Epub 2018 May 31.
PubMed 31047549Miyata M, Ooto S, Hata M, Yamashiro K, Tamura H, Akagi-Kurashige Y, Nakanishi H, Ueda-Arakawa N, Takahashi A, Kuroda Y, Wakazono T, Yoshikawa M, Yoshimura N. Detection of Myopic Choroidal Neovascularization Using Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 May;165:108-14. doi: 10.1016/j.ajo.2016.03.009. Epub 2016 Mar 10.
PubMed 26973049Rocholz R, Corvi F, Weichsel J, Schmidt S, Staurenghi G. OCT Angiography (OCTA) in Retinal Diagnostics. 2019 Aug 14. In: Bille JF, editor. High Resolution Imaging in Microscopy and Ophthalmology: New Frontiers in Biomedical Optics [Internet]. Cham (CH): Springer; 2019. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK554041/
PubMed 32091844Li S, Sun L, Zhao X, Huang S, Luo X, Zhang A, Chen C, Wang Z, Liu C, Ding X. ASSESSING THE ACTIVITY OF MYOPIC CHOROIDAL NEOVASCULARIZATION: Comparison Between Optical Coherence Tomography Angiography and Dye Angiography. Retina. 2020 Sep;40(9):1757-1764. doi: 10.1097/IAE.0000000000002650.
PubMed 31652198Zhu Y, Zhang T, Xu G, Peng L. Anti-vascular endothelial growth factor for choroidal neovascularisation in people with pathological myopia. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD011160. doi: 10.1002/14651858.CD011160.pub2.
PubMed 27977064Soubrane G. Choroidal neovascularization in pathologic myopia: recent developments in diagnosis and treatment. Surv Ophthalmol. 2008 Mar-Apr;53(2):121-38. doi: 10.1016/j.survophthal.2007.12.004.
PubMed 18348878Wong TY, Ferreira A, Hughes R, Carter G, Mitchell P. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence-based systematic review. Am J Ophthalmol. 2014 Jan;157(1):9-25.e12. doi: 10.1016/j.ajo.2013.08.010. Epub 2013 Oct 5.
PubMed 24099276Mi L, Zuo C, Zhang X, Liu B, Peng Y, Wen F. Fluorescein Leakage within Recent Subretinal Hemorrhage in Pathologic Myopia: Suggestive of CNV? J Ophthalmol. 2018 Aug 13;2018:4707832. doi: 10.1155/2018/4707832. eCollection 2018.
PubMed 30186627
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning-Based OCTA Quantification and Modeling for Predicting Long-Term Anti-VEGF Efficacy in mCNV
- ClinicalTrials.gov ID
- NCT07402629
- Acronym / sponsor ID
- 2025-1039
- Conditions
- Myopic Choroidal Neovascularization
- Keywords
- Deep learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Feb 2026 (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.
Myopic choroidal neovascularization (mCNV) is one of the sight-threatening complications secondary to pathological myopia. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is its first-line therapy. However, mCNV is prone to recurrence and long-term visual decline, and there is currently no definitive method for predicting long-term prognosis. This project aims to conduct a long-term follow-up and multi-dimensional quantitative analysis of mCNV using optical coherence tomography angiography (OCTA) images. It seeks to evaluate long-term prognostic indicators, such as recurrence and long-term visual acuity, following anti-VEGF therapy for mCNV, and to construct a deep learning (DL) prediction model for anti-VEGF efficacy based on multi-modal clinical data, ultimately enabling treatment personalization.
First, deep learning technology will be utilized to segment and quantitatively analyze mCNV in OCTA images, obtaining multi-dimensional quantitative parameters. These include OCTA-based The mCNV area and vessel junction(VJ). Patients will be followed up regularly for two years post-treatment, monitoring the number of injections, mCNV recurrence, OCT and OCTA quantitative parameters, fundus chorioretinal atrophy lesions, and visual acuity status. A multi-modal DL prediction model will be constructed, primarily based on the multi-dimensional quantitative characteristics of mCNV from OCTA images. This model will aim to identify sensitive indicators for predicting best-corrected visual acuity and recurrence after anti-VEGF therapy for mCNV and to clarify the relationship between therapeutic efficacy, baseline lesion status, and treatment regimen selection.
This research will open new avenues for clinically assessing the long-term efficacy of anti-VEGF therapy for mCNV, significantly improve the efficiency and accuracy of efficacy evaluation, and provide a critical reference for personalizing anti-VEGF treatment plans, holding substantial clinical significance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve patients with active mCNV at initial diagnosis, scheduled for intravitreal anti-VEGF | – | Other: No interventions beyond routine medical care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with initially diagnosed, treatment-naïve active mCNV who are scheduled to undergo intravitreal anti-VEGF injection.
Key inclusion criteria (5 listed)
- Myopic spherical equivalent greater than -6.0 diopters and/or axial length > 26.5 mm.
- Patients presenting with myopic fundus changes, as defined by the International Photographic Classification System for Myopic Maculopathy.
- Completion of a comprehensive ophthalmic examination at initial diagnosis, including Best Corrected Visual Acuity , slit-lamp examination, dilated fundus examination, intraocular pressure measurement, refractometry, axial length measurement, color fundus photography, Optical Coherence Tomography, OCT Angiography, and Fundus Fluorescein Angiography.
- Patients with active mCNV at initial diagnosis who are treatment-naïve.
- Final inclusion of all images required confirmation by two retinal specialists. Images with discrepant assessments were adjudicated by a senior researcher to reach a final decision.
Key exclusion criteria (4 listed)
- Patients with choroidal neovascularization (CNV) due to causes other than myopia, such as age-related macular degeneration, adult-onset foveomacular vitelliform dystrophy, multifocal choroiditis, punctate inner choroidopathy, or retinoschisis.
- Poor-quality OCTA images, for example, those containing projection artifacts from overlying vessels at the mCNV lesion site, or excessively dark images dominated by thick outer choroidal vessels.
- Patients with a history of intraocular surgery, such as prior pars plana vitrectomy.
- Subjects who developed any of the above conditions during the follow-up period or who requested to withdraw from the study were removed from the experimental cohort.
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 |
|---|---|---|
| No interventions beyond routine medical careNo interventions beyond routine medical care | Other | Treatment-naïve patients with active mCNV at initial diagnosis, scheduled for intravitreal anti-VEGF |
Primary outcome
Change in Best-Corrected Visual Acuity at 24 Months
Time frame: Baseline to 24 months
This outcome evaluates the change in best-corrected visual acuity (BCVA) from baseline to 24 months in eyes with myopic choroidal neovascularization receiving intravitreal anti-vascular endothelial growth factor treatment as part of routine clinical care. BCVA reflects functional visual outcome and is measured at each visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under standardized testing conditions. BCVA values are recorded as ETDRS letter scores, and the primary assessment is the within-eye change from baseline to the 24-month follow-up visit.
Number of Recurrence Events During 24-Month Follow-up
Time frame: Baseline to 24 months
This outcome assesses disease activity by quantifying the number of recurrence events during the 24-month follow-up period in eyes with myopic choroidal neovascularization treated with intravitreal anti-vascular endothelial growth factor therapy. Recurrence is defined as the reappearance of active myopic choroidal neovascularization following an initial treatment response, as determined by clinical examination and imaging findings, including evidence of lesion activity that necessitates additional anti-vascular endothelial growth factor treatment.
2 secondary outcomes
Change in Myopic Choroidal Neovascularization Area at 24 Months
Time frame: Baseline to 24 months
Change In Number of Vessel Junctions at 24 Months
Time frame: Baseline to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Results publication: PubMed 24075429Yang HS, Kim JG, Kim JT, Joe SG. Prognostic factors of eyes with naive subfoveal myopic choroidal neovascularization after intravitreal bevacizumab. Am J Ophthalmol. 2013 Dec;156(6):1201-1210.e2. doi: 10.1016/j.ajo.2013.08.002. Epub 2013 Sep 25.
- Results publication: PubMed 34026789Wang Y, Hu Z, Zhu T, Su Z, Fang X, Lin J, Chen Z, Su Z, Ye P, Ma J, Zhang L, Li J, Feng L, Sun CB, Zhang Z, Shentu X. Optical Coherence Tomography Angiography-Based Quantitative Assessment of Morphologic Changes in Active Myopic Choroidal Neovascularization During Anti-vascular Endothelial Growth Factor Therapy. Front Med (Lausanne). 2021 May 7;8:657772. doi: 10.3389/fmed.2021.657772. eCollection 2021.
- Results publication: PubMed 31047549Hosoda Y, Miyata M, Uji A, Ooto S, Yamashiro K, Tamura H, Oishi A, Ueda-Arakawa N, Miyake M, Hata M, Muraoka Y, Takahashi A, Tsujikawa A. Novel Predictors of Visual Outcome in Anti-VEGF Therapy for Myopic Choroidal Neovascularization Derived Using OCT Angiography. Ophthalmol Retina. 2018 Nov;2(11):1118-1124. doi: 10.1016/j.oret.2018.04.011. Epub 2018 May 31.
- Results publication: PubMed 26973049Miyata M, Ooto S, Hata M, Yamashiro K, Tamura H, Akagi-Kurashige Y, Nakanishi H, Ueda-Arakawa N, Takahashi A, Kuroda Y, Wakazono T, Yoshikawa M, Yoshimura N. Detection of Myopic Choroidal Neovascularization Using Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 May;165:108-14. doi: 10.1016/j.ajo.2016.03.009. Epub 2016 Mar 10.
- Results publication: PubMed 32091844Rocholz R, Corvi F, Weichsel J, Schmidt S, Staurenghi G. OCT Angiography (OCTA) in Retinal Diagnostics. 2019 Aug 14. In: Bille JF, editor. High Resolution Imaging in Microscopy and Ophthalmology: New Frontiers in Biomedical Optics [Internet]. Cham (CH): Springer; 2019. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK554041/
- Results publication: PubMed 31652198Li S, Sun L, Zhao X, Huang S, Luo X, Zhang A, Chen C, Wang Z, Liu C, Ding X. ASSESSING THE ACTIVITY OF MYOPIC CHOROIDAL NEOVASCULARIZATION: Comparison Between Optical Coherence Tomography Angiography and Dye Angiography. Retina. 2020 Sep;40(9):1757-1764. doi: 10.1097/IAE.0000000000002650.
- Results publication: PubMed 27977064Zhu Y, Zhang T, Xu G, Peng L. Anti-vascular endothelial growth factor for choroidal neovascularisation in people with pathological myopia. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD011160. doi: 10.1002/14651858.CD011160.pub2.
- Results publication: PubMed 18348878Soubrane G. Choroidal neovascularization in pathologic myopia: recent developments in diagnosis and treatment. Surv Ophthalmol. 2008 Mar-Apr;53(2):121-38. doi: 10.1016/j.survophthal.2007.12.004.
- Results publication: PubMed 24099276Wong TY, Ferreira A, Hughes R, Carter G, Mitchell P. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence-based systematic review. Am J Ophthalmol. 2014 Jan;157(1):9-25.e12. doi: 10.1016/j.ajo.2013.08.010. Epub 2013 Oct 5.
- Results publication: PubMed 30186627Mi L, Zuo C, Zhang X, Liu B, Peng Y, Wen F. Fluorescein Leakage within Recent Subretinal Hemorrhage in Pathologic Myopia: Suggestive of CNV? J Ophthalmol. 2018 Aug 13;2018:4707832. doi: 10.1155/2018/4707832. eCollection 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopic Choroidal Neovascularization, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 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: opening soon, as of the sponsor's last update on 11 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Wang 王 (+8613968028750, wangyao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-Corrected Visual Acuity at 24 Months (time frame: Baseline to 24 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 NCT07402629, which also lists 10 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 11 Feb 2026.