Primary Angle Closure GlaucomaTVGNCT05163951
Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
A study testing Trabeculectomy and SPI+GSL+GT in people with Primary Angle Closure Glaucoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
A multicenter, parallel, open, non-inferior randomized controlled trial is conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma with no or mild cataracts. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Primary Angle Closure Glaucoma
- What is being tested?
- Trabeculectomy and SPI+GSL+GT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-80 years.
- Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:
- PAS: ≥180° range, including nasal and inferior quadrants;
- IOP >21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer;
- Glaucomatous optic neuropathy (cup-to-disc [C/D] ratio ≥0.7, C/D asymmetry >0.2, or rim width at the superior and inferior temporal areas <0.1 of the vertical diameters of the optic disc);
- Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).
- No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);
- Axial length of ≥20 mm.
Who cannot join
- History of ocular surgery or trauma.
- Retinal disease that influences the collection of ocular parameters or other types of glaucoma, including open-angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle recession glaucoma, neovascular glaucoma, nanophthalmos, and pseudoexfoliation syndrome.
- Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye).
- An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery.
- Patients with serious systemic diseases.
- Pregnant or lactating women.
- If both eyes are eligible for the study, the eye with the worse visual field or optic nerve will be included.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Xiulan Zhang, MD, PhD, +86 13059106657, zhangxl2@mail.sysu.edu.cn
Xinbo Gao, MD, PhD, +86 18319579657, gaoxb@mail.sysu.edu.cn
About this study
Official title: Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial
A multicenter, parallel, open, non-inferior randomized controlled trial is conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma with no or mild cataracts.
Read the detailed description
Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative.
Minimally invasive glaucoma surgery (MIGS) has recently showed its safety and effectiveness in the treatment of PACG, usually combined with cataract surgery, goniosynechialysis (GSL) and goniotomy(GT). The safety and effectiveness of phacoemulsification and intraocular lens implantation (PEI)+GSL+GT in advanced PACG with cataract has been conducted (clinical trials.gov, NCT04878458). It is valuable to explore the safety and efficacy of SPI+GSL+GT in these PACG patients with no or mild cataracts.
Therefore, this study intends to conduct a multicenter, non-inferior randomized controlled clinical trial to compare the effectiveness and safety of trabeculectomy versus SPI+GSL+GT in advanced PACG with no or mild cataracts.
- Conditions
- Primary Angle Closure Glaucoma
- Being tested
- Trabeculectomy, SPI+GSL+GT
- Keywords
- angle closure, glaucoma
- Medical subject headings
- Glaucoma, Angle-Closure, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabeculectomyProcedure or surgery
trabeculectomy
SPI+GSL+GTProcedure or surgery
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy | Active comparator | Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy. Receives: Procedure: Trabeculectomy |
| SPI+GSL+GT | Experimental | Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT). Receives: Procedure: SPI+GSL+GT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure at postoperative 12 months
Intraocular pressure after surgery using Goldmann or non-contact tonometer.
Measured: Postoperative 12 month
Secondary outcomes (3)
Cumulative success rate of surgery
Cumulative success rate of surgery is defined as :
(i) Complete success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline without anti-glaucoma medications.
(ii) Qualified success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline with anti-glaucoma medications.
Measured: Postoperative 12, 24, 36 months
Intraoperative and postoperative complications
Intraoperative and postoperative complications, such as shallow anterior chamber, malignant glaucoma, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and bleb-related complications.
Measured: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
The numbers of anti-glaucoma medications
Numbers of anti-glaucoma medications.
Measured: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start5 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Primary Angle Closure GlaucomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, parallel, open, non-inferior randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, First Hospital of Shijiazhuang City, West China Hospital, Chongqing Medical University, Handan City Eye Hospital, People's Hospital of Chongqing
- Responsible party
- Principal investigator, Xiulan Zhang, Sun Yat-sen University
- Investigators
- Xiulan Zhang, MD. PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163951
- Sponsor's protocol ID
- 2021KYPJ191
- Acronym
- TVG
- Status last verified
- Jun 2022
- First submitted
- 25 Nov 2021
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Husain R, Do T, Lai J, Kitnarong N, Nongpiur ME, Perera SA, Ho CL, Lim SK, Aung T. Efficacy of Phacoemulsification Alone vs Phacoemulsification With Goniosynechialysis in Patients With Primary Angle-Closure Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Oct 1;137(10):1107-1113. doi: 10.1001/jamaophthalmol.2019.2493.
PubMed 31294768Barry M, Alahmadi MW, Alahmadi M, AlMuzaini A, AlMohammadi M. The Safety of the Kahook Dual Blade in the Surgical Treatment of Glaucoma. Cureus. 2020 Jan 16;12(1):e6682. doi: 10.7759/cureus.6682.
PubMed 31976190Tanito M, Sugihara K, Tsutsui A, Hara K, Manabe K, Matsuoka Y. Midterm Results of Microhook ab Interno Trabeculotomy in Initial 560 Eyes with Glaucoma. J Clin Med. 2021 Feb 17;10(4):814. doi: 10.3390/jcm10040814.
PubMed 33671386Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956.
PubMed 29613978Dorairaj S, Tam MD, Balasubramani GK. Two-Year Clinical Outcomes of Combined Phacoemulsification, Goniosynechialysis, and Excisional Goniotomy For Angle-Closure Glaucoma. Asia Pac J Ophthalmol (Phila). 2020 Oct 6;10(2):183-187. doi: 10.1097/APO.0000000000000321.
PubMed 33031110Tham CC, Kwong YY, Baig N, Leung DY, Li FC, Lam DS. Phacoemulsification versus trabeculectomy in medically uncontrolled chronic angle-closure glaucoma without cataract. Ophthalmology. 2013 Jan;120(1):62-7. doi: 10.1016/j.ophtha.2012.07.021. Epub 2012 Sep 15.
PubMed 22986111Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
PubMed 31727428Lin F, Lv A, Li F, Song Y, Xie L, Zhu X, Tang L, Zhang Y, Huang J, Tang G, Zhang H, Lu L, Xiao M, Xu J, Nie X, Liao M, Yang Y, Gao K, Yuan H, Song W, Zuo C, Lu P, Yan X, Zhou F, Wang Z, Jin L, Peng Y, Chen W, Barton K, Park KH, Aung T, Lam DSC, Weinreb RN, Wang N, Tham CC, Fan S, Zhang X; TVG study group. Peripheral Iridectomy With Goniosynechialysis and Goniotomy vs Trabeculectomy for Advanced PACG: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jun 1;143(6):472-479. doi: 10.1001/jamaophthalmol.2025.0757.
PubMed 40244579Gao X, Lv A, Lin F, Lu P, Zhang Y, Song W, Zhu X, Zhang H, Liao M, Song Y, Hu K, Zhang Y, Peng Y, Tang L, Yuan H, Xie L, Tang G, Nie X, Jin L, Fan S, Zhang X; TVG study group. Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study). BMJ Open. 2022 Jul 4;12(7):e062441. doi: 10.1136/bmjopen-2022-062441.
PubMed 35788072
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05163951
- Acronym / sponsor ID
- TVG / 2021KYPJ191
- Conditions
- Primary Angle Closure Glaucoma
- Keywords
- angle closure, glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, First Hospital of Shijiazhuang City, West China Hospital, Chongqing Medical University, Handan City Eye Hospital, People's Hospital of Chongqing
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, parallel, open, non-inferior randomized controlled trial is conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma with no or mild cataracts.
Detailed description
Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative.
Minimally invasive glaucoma surgery (MIGS) has recently showed its safety and effectiveness in the treatment of PACG, usually combined with cataract surgery, goniosynechialysis (GSL) and goniotomy(GT). The safety and effectiveness of phacoemulsification and intraocular lens implantation (PEI)+GSL+GT in advanced PACG with cataract has been conducted (clinical trials.gov, NCT04878458). It is valuable to explore the safety and efficacy of SPI+GSL+GT in these PACG patients with no or mild cataracts.
Therefore, this study intends to conduct a multicenter, non-inferior randomized controlled clinical trial to compare the effectiveness and safety of trabeculectomy versus SPI+GSL+GT in advanced PACG with no or mild cataracts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, parallel, open, non-inferior randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy | Active comparator | Procedure: TrabeculectomyForty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy. |
| SPI+GSL+GT | Experimental | Procedure: SPI+GSL+GTForty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 45-80 years.
- Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:
- No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);
- Axial length of ≥20 mm.
Key exclusion criteria (7 listed)
- History of ocular surgery or trauma.
- Retinal disease that influences the collection of ocular parameters or other types of glaucoma, including open-angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle recession glaucoma, neovascular glaucoma, nanophthalmos, and pseudoexfoliation syndrome.
- Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye).
- An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery.
- Patients with serious systemic diseases.
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 |
|---|---|---|
| Trabeculectomytrabeculectomy | Procedure or surgery | Trabeculectomy |
| SPI+GSL+GTPeripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT) | Procedure or surgery | SPI+GSL+GT |
Primary outcome
Intraocular pressure at postoperative 12 months
Time frame: Postoperative 12 month
Intraocular pressure after surgery using Goldmann or non-contact tonometer.
3 secondary outcomes
Cumulative success rate of surgery
Time frame: Postoperative 12, 24, 36 months
Intraoperative and postoperative complications
Time frame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
The numbers of anti-glaucoma medications
Time frame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Results publication: PubMed 31294768Husain R, Do T, Lai J, Kitnarong N, Nongpiur ME, Perera SA, Ho CL, Lim SK, Aung T. Efficacy of Phacoemulsification Alone vs Phacoemulsification With Goniosynechialysis in Patients With Primary Angle-Closure Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Oct 1;137(10):1107-1113. doi: 10.1001/jamaophthalmol.2019.2493.
- Results publication: PubMed 31976190Barry M, Alahmadi MW, Alahmadi M, AlMuzaini A, AlMohammadi M. The Safety of the Kahook Dual Blade in the Surgical Treatment of Glaucoma. Cureus. 2020 Jan 16;12(1):e6682. doi: 10.7759/cureus.6682.
- Results publication: PubMed 33671386Tanito M, Sugihara K, Tsutsui A, Hara K, Manabe K, Matsuoka Y. Midterm Results of Microhook ab Interno Trabeculotomy in Initial 560 Eyes with Glaucoma. J Clin Med. 2021 Feb 17;10(4):814. doi: 10.3390/jcm10040814.
- Results publication: PubMed 29613978Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956.
- Results publication: PubMed 33031110Dorairaj S, Tam MD, Balasubramani GK. Two-Year Clinical Outcomes of Combined Phacoemulsification, Goniosynechialysis, and Excisional Goniotomy For Angle-Closure Glaucoma. Asia Pac J Ophthalmol (Phila). 2020 Oct 6;10(2):183-187. doi: 10.1097/APO.0000000000000321.
- Results publication: PubMed 22986111Tham CC, Kwong YY, Baig N, Leung DY, Li FC, Lam DS. Phacoemulsification versus trabeculectomy in medically uncontrolled chronic angle-closure glaucoma without cataract. Ophthalmology. 2013 Jan;120(1):62-7. doi: 10.1016/j.ophtha.2012.07.021. Epub 2012 Sep 15.
- Results publication: PubMed 31727428Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
- Derived from this study: PubMed 40244579Lin F, Lv A, Li F, Song Y, Xie L, Zhu X, Tang L, Zhang Y, Huang J, Tang G, Zhang H, Lu L, Xiao M, Xu J, Nie X, Liao M, Yang Y, Gao K, Yuan H, Song W, Zuo C, Lu P, Yan X, Zhou F, Wang Z, Jin L, Peng Y, Chen W, Barton K, Park KH, Aung T, Lam DSC, Weinreb RN, Wang N, Tham CC, Fan S, Zhang X; TVG study group. Peripheral Iridectomy With Goniosynechialysis and Goniotomy vs Trabeculectomy for Advanced PACG: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jun 1;143(6):472-479. doi: 10.1001/jamaophthalmol.2025.0757.
- Derived from this study: PubMed 35788072Gao X, Lv A, Lin F, Lu P, Zhang Y, Song W, Zhu X, Zhang H, Liao M, Song Y, Hu K, Zhang Y, Peng Y, Tang L, Yuan H, Xie L, Tang G, Nie X, Jin L, Fan S, Zhang X; TVG study group. Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study). BMJ Open. 2022 Jul 4;12(7):e062441. doi: 10.1136/bmjopen-2022-062441.
- 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.
Xiulan Zhang, MD. PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabeculectomy and SPI+GSL+GT in people with Primary Angle Closure Glaucoma, run by Sun Yat-sen 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 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiulan Zhang, MD. PhD (+86 13570166308, zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure at postoperative 12 months (time frame: Postoperative 12 month). 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 NCT05163951, which also lists 9 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 14 Jun 2022.