Uveitis, AnteriorPhase 4NCT05015335
The Efficacy and Safety of Adalimumab in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage
A Phase 4 study testing Adalimumab and Methotrexate in people with Uveitis, Anterior and Adalimumab, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Children with anterior uveitis are prone to suffer from chronic recurrent course of intraocular inflammation and adverse effects of glucocorticosteroids (GCs) /immunomodulatory treatment (IMT) agents. The performance of adalimumab has been shown to be fairly favorable in treating refractory non-infectious uveitis. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Uveitis, Anterior, Adalimumab
- What is being tested?
- Adalimumab and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2021to Jul 2023
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with noninfectious uveitis aged between 4-16, weight ≥ 30kg.
- Uveitis resistant to well conducted topical steroid therapy for three months, or uveitis resistant to well conducted 0.1% prednisolone twice a day for one month
- Retina peripheral vascular leakage demonstrated by UWFFA at the time of inclusion.
Who cannot join
- Any contraindication to administration of immunosuppressive therapy (active tuberculosis, immune deficit, opportunistic infection, other severe chronic disease).
- Previous diagnosis or signs of demyelinating disease of the central nervous system.
- Children unable to cooperate with examinations and follow-up.
- Positive allergy skin test when conducting fluorescence fundus angiography.
- Diffuse vascular leakage, macula edema or any retina lesions demonstrated by UWFFA.
- History of oral immunosuppressive drug treatment within 2 months
Show all 11Show fewer
- History of biological treatment within 2 months
- History of triamcinolone acetonide subconjunctival/intraocular injection within 3 months
- Current topical steroid use more than six times per day
- History of eye surgery within 3 months.
- Eye complications that interfere with fundus observation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Medical College Hospital
Beijing, 100000
Hang Hang, MD, +15600612346, songhang_pumch@163.com
About this study
Official title: The Efficacy and Safety of Adalimumab for Inflammatory Flare Prevention in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage Compared With Methotrexate, a RCT Study
Children with anterior uveitis are prone to suffer from chronic recurrent course of intraocular inflammation and adverse effects of glucocorticosteroids (GCs) /immunomodulatory treatment (IMT) agents. The performance of adalimumab has been shown to be fairly favorable in treating refractory non-infectious uveitis. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious anterior pediatric uveitis with peripheral vascular leakage compared with methotrexate. Children weighed ≥ 30kg and aged between 4-16 years old with active chronic non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra wildfield fluorescence fundus angiography (UWFFA) will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either MTX or adalimumab and regularly followed up for at least 6 months. The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1. Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.
Read the detailed description
This is a prospective, single-center, interventional, randomized, non-blinded, controlled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital.
Children with active noninfectious anterior uveitis demonstrating peripheral vascular leakage on UWFFA and meet the selection criteria will be randomly assigned to treatment group or control group.
Both groups will be treated with a predesigned plan for the active inflammation. At one month or when patients' ocular inflammation gets controlled to 0.5+ cell in the anterior chamber, whichever comes later, patients in the treatment group will be given adalimumab subcutaneously at 40mg every 2 weeks, patients in the control group will be given methotrexate10mg orally once a week.
Follow-up visits will be scheduled every two weeks at the run-in period and the first month after randomization, and every month from the second to the sixth month.
The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1.
Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.
- Conditions
- Uveitis, Anterior, Adalimumab
- Being tested
- Adalimumab, Methotrexate
- Keywords
- pheripheral retinal vasuclar leakage, adalimumab, methotrexate
- Medical subject headings
- Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called ADA
ADA 40mg q2w
MethotrexateDrug
Also called MTX
MTX 10mg qw
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Adalimumab administered subcutaneously at 40mg every 2 weeks Receives: Drug: Adalimumab |
| Methotrexate | Active comparator | Methotrexate given 10mg orally once a week. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uveitis flare
Uveitis flare is defined as anterior chamber cell count grading increased from 0 to 1.
The grading method is in accordance with SUN criteria. Anterior chamber cell count was scored according to Standardization of Uveitis Nomenclature (SUN) criteria
Measured: At 6 months' follow-up visit
Secondary outcomes (7)
Extent of peripheral vascular leakage
Vascular leakage was quantified based on the method developed by the Angiography Scoring for Uveitis Working Group (ASUWOG), in which vascular leakage in the posterior pole and in each peripheral quadrant was scored 1 if limited and scored 2 if diffuse. Total maximum score will 8 since leakage in the posterior pole will be excluded in this study.
Measured: At 6 months' follow-up visit
Keratic precipitates
Keratic precipitates was recorded in a dichotomous method.
Measured: At 6 months' follow-up visit
Vitreous haze
Vitreous haze will graded as the same method of anterior chamber cell, the slit lamp will be pushed forward to the vitreous to observe vitreous haze.
Measured: At 6 months' follow-up visit
Best corrected visual acuity (BCVA)
BCVA was transformed into logMar form
Measured: At 6 months' follow-up visit
Adverse events
Adverse events included the infectious events and laboratory parameter abnormalities.
Measured: through study completion, an average of 6 months
frequency of topical steroid eyedrops if any inflammatory flare happens.
Different GCs eye drops are transformed into equivalent 1% prednisolone for analysis.
Measured: At 6 months' follow-up visit
Systemic immunomodulatory therapy (sIMT, including GCs and immunosuppressive drugs)load at the 6-month follow-up visit if any inflammatory flare ever happens.
sIMT load is transformed into a quantizable score based on prior studies in uveitis.
Measured: At 6 months' follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start19 Aug 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uveitis, AnteriorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center,open-lablel, interventional, randomizedcontrolled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meifen Zhang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015335
- Sponsor's protocol ID
- 25-ZS-3062
- Status last verified
- Jul 2021
- First submitted
- 10 Aug 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: If other researcher needs the IPD. Please contact songhang\_pumch@163.com
Publications
Agrawal R, Agarwal A, Jabs DA, Kee A, Testi I, Mahajan S, McCluskey PJ, Gupta A, Palestine A, Denniston A, Banker A, Invernizzi A, Fonollosa A, Sharma A, Kumar A, Curi A, Okada A, Schlaen A, Heiligenhaus A, Kumar A, Gurbaxani A, Bodaghi B, Islam Shah B, Lowder C, Tappeiner C, Muccioli C, Vasconcelos-Santos DV, Goldstein D, Behra D, Das D, Makhoul D, Baglivo E, Denisova E, Miserocchi E, Carreno E, Asyari F, Pichi F, Sen HN, Uy H, Nascimento H, Tugal-Tutkun I, Arevalo JF, Davis J, Thorne J, Hisae Yamamoto J, Smith J, Garweg JG, Biswas J, Babu K, Aggarwal K, Cimino L, Kuffova L, Agarwal M, Zierhut M, Agarwal M, De Smet M, Tognon MS, Errera MH, Munk M, Westcott M, Soheilian M, Accorinti M, Khairallah M, Nguyen M, Kon OM, Mahendradas P, Yang P, Neri P, Ozdal P, Amer R, Lee R, Distia Nora R, Chhabra R, Belfort R, Mehta S, Shoughy S, Luthra S, Mohamed SO, Chee SP, Basu S, Teoh S, Ganesh S, Barisani-Asenbauer T, Guex-Crosier Y, Ozyazgan Y, Akova Y, Habot-Wilner Z, Kempen J, Nguyen QD, Pavesio C, Gupta V; Collaborative Ocular Tuberculosis Study (COTS) Group. Standardization of Nomenclature for Ocular Tuberculosis - Results of Collaborative Ocular Tuberculosis Study (COTS) Workshop. Ocul Immunol Inflamm. 2020 Sep 30;28(sup1):74-84. doi: 10.1080/09273948.2019.1653933. Epub 2019 Dec 10.
PubMed 31821096Nussenblatt RB, Peterson JS, Foster CS, Rao NA, See RF, Letko E, Buggage RR. Initial evaluation of subcutaneous daclizumab treatments for noninfectious uveitis: a multicenter noncomparative interventional case series. Ophthalmology. 2005 May;112(5):764-70. doi: 10.1016/j.ophtha.2004.12.034.
PubMed 15878055Tugal-Tutkun I, Herbort CP, Khairallah M; Angiography Scoring for Uveitis Working Group (ASUWOG). Scoring of dual fluorescein and ICG inflammatory angiographic signs for the grading of posterior segment inflammation (dual fluorescein and ICG angiographic scoring system for uveitis). Int Ophthalmol. 2010 Oct;30(5):539-52. doi: 10.1007/s10792-008-9263-x. Epub 2008 Sep 16.
PubMed 18795232Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Compeyrot-Lacassagne S, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW; SYCAMORE Study Group. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017 Apr 27;376(17):1637-1646. doi: 10.1056/NEJMoa1614160.
PubMed 28445659Song H, Zhao C, Zhang Y, Li D, Qian Y, Gao F, Xiao J, Zhang M. Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial. BMJ Open. 2022 Dec 7;12(12):e062211. doi: 10.1136/bmjopen-2022-062211.
PubMed 36600374
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Adalimumab for Inflammatory Flare Prevention in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage Compared With Methotrexate, a RCT Study
- ClinicalTrials.gov ID
- NCT05015335
- Acronym / sponsor ID
- 25-ZS-3062
- Conditions
- Uveitis, Anterior, Adalimumab
- Keywords
- pheripheral retinal vasuclar leakage, adalimumab, methotrexate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 20 Aug 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.
Children with anterior uveitis are prone to suffer from chronic recurrent course of intraocular inflammation and adverse effects of glucocorticosteroids (GCs) /immunomodulatory treatment (IMT) agents. The performance of adalimumab has been shown to be fairly favorable in treating refractory non-infectious uveitis. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious anterior pediatric uveitis with peripheral vascular leakage compared with methotrexate. Children weighed ≥ 30kg and aged between 4-16 years old with active chronic non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra wildfield fluorescence fundus angiography (UWFFA) will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either MTX or adalimumab and regularly followed up for at least 6 months. The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1. Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.
Detailed description
This is a prospective, single-center, interventional, randomized, non-blinded, controlled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital.
Children with active noninfectious anterior uveitis demonstrating peripheral vascular leakage on UWFFA and meet the selection criteria will be randomly assigned to treatment group or control group.
Both groups will be treated with a predesigned plan for the active inflammation. At one month or when patients' ocular inflammation gets controlled to 0.5+ cell in the anterior chamber, whichever comes later, patients in the treatment group will be given adalimumab subcutaneously at 40mg every 2 weeks, patients in the control group will be given methotrexate10mg orally once a week.
Follow-up visits will be scheduled every two weeks at the run-in period and the first month after randomization, and every month from the second to the sixth month.
The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1.
Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, single-center,open-lablel, interventional, randomizedcontrolled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital.
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: AdalimumabAdalimumab administered subcutaneously at 40mg every 2 weeks |
| Methotrexate | Active comparator | Drug: MethotrexateMethotrexate given 10mg orally once a week. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with noninfectious uveitis aged between 4-16, weight ≥ 30kg.
- Uveitis resistant to well conducted topical steroid therapy for three months, or uveitis resistant to well conducted 0.1% prednisolone twice a day for one month
- Retina peripheral vascular leakage demonstrated by UWFFA at the time of inclusion.
Key exclusion criteria (11 listed)
- Any contraindication to administration of immunosuppressive therapy (active tuberculosis, immune deficit, opportunistic infection, other severe chronic disease).
- Previous diagnosis or signs of demyelinating disease of the central nervous system.
- Children unable to cooperate with examinations and follow-up.
- Positive allergy skin test when conducting fluorescence fundus angiography.
- Diffuse vascular leakage, macula edema or any retina lesions demonstrated by UWFFA.
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 |
|---|---|---|
| AdalimumabAlso: ADAADA 40mg q2w | Drug | Adalimumab |
| MethotrexateAlso: MTXMTX 10mg qw | Drug | Methotrexate |
Primary outcome
Uveitis flare
Time frame: At 6 months' follow-up visit
Uveitis flare is defined as anterior chamber cell count grading increased from 0 to 1. The grading method is in accordance with SUN criteria. Anterior chamber cell count was scored according to Standardization of Uveitis Nomenclature (SUN) criteria
7 secondary outcomes
Extent of peripheral vascular leakage
Time frame: At 6 months' follow-up visit
Keratic precipitates
Time frame: At 6 months' follow-up visit
Vitreous haze
Time frame: At 6 months' follow-up visit
Best corrected visual acuity (BCVA)
Time frame: At 6 months' follow-up visit
Adverse events
Time frame: through study completion, an average of 6 months
frequency of topical steroid eyedrops if any inflammatory flare happens.
Time frame: At 6 months' follow-up visit
Systemic immunomodulatory therapy (sIMT, including GCs and immunosuppressive drugs)load at the 6-month follow-up visit if any inflammatory flare ever happens.
Time frame: At 6 months' follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 31821096Agrawal R, Agarwal A, Jabs DA, Kee A, Testi I, Mahajan S, McCluskey PJ, Gupta A, Palestine A, Denniston A, Banker A, Invernizzi A, Fonollosa A, Sharma A, Kumar A, Curi A, Okada A, Schlaen A, Heiligenhaus A, Kumar A, Gurbaxani A, Bodaghi B, Islam Shah B, Lowder C, Tappeiner C, Muccioli C, Vasconcelos-Santos DV, Goldstein D, Behra D, Das D, Makhoul D, Baglivo E, Denisova E, Miserocchi E, Carreno E, Asyari F, Pichi F, Sen HN, Uy H, Nascimento H, Tugal-Tutkun I, Arevalo JF, Davis J, Thorne J, Hisae Yamamoto J, Smith J, Garweg JG, Biswas J, Babu K, Aggarwal K, Cimino L, Kuffova L, Agarwal M, Zierhut M, Agarwal M, De Smet M, Tognon MS, Errera MH, Munk M, Westcott M, Soheilian M, Accorinti M, Khairallah M, Nguyen M, Kon OM, Mahendradas P, Yang P, Neri P, Ozdal P, Amer R, Lee R, Distia Nora R, Chhabra R, Belfort R, Mehta S, Shoughy S, Luthra S, Mohamed SO, Chee SP, Basu S, Teoh S, Ganesh S, Barisani-Asenbauer T, Guex-Crosier Y, Ozyazgan Y, Akova Y, Habot-Wilner Z, Kempen J, Nguyen QD, Pavesio C, Gupta V; Collaborative Ocular Tuberculosis Study (COTS) Group. Standardization of Nomenclature for Ocular Tuberculosis - Results of Collaborative Ocular Tuberculosis Study (COTS) Workshop. Ocul Immunol Inflamm. 2020 Sep 30;28(sup1):74-84. doi: 10.1080/09273948.2019.1653933. Epub 2019 Dec 10.
- Background: PubMed 15878055Nussenblatt RB, Peterson JS, Foster CS, Rao NA, See RF, Letko E, Buggage RR. Initial evaluation of subcutaneous daclizumab treatments for noninfectious uveitis: a multicenter noncomparative interventional case series. Ophthalmology. 2005 May;112(5):764-70. doi: 10.1016/j.ophtha.2004.12.034.
- Background: PubMed 18795232Tugal-Tutkun I, Herbort CP, Khairallah M; Angiography Scoring for Uveitis Working Group (ASUWOG). Scoring of dual fluorescein and ICG inflammatory angiographic signs for the grading of posterior segment inflammation (dual fluorescein and ICG angiographic scoring system for uveitis). Int Ophthalmol. 2010 Oct;30(5):539-52. doi: 10.1007/s10792-008-9263-x. Epub 2008 Sep 16.
- Results publication: PubMed 28445659Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Compeyrot-Lacassagne S, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW; SYCAMORE Study Group. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017 Apr 27;376(17):1637-1646. doi: 10.1056/NEJMoa1614160.
- Derived from this study: PubMed 36600374Song H, Zhao C, Zhang Y, Li D, Qian Y, Gao F, Xiao J, Zhang M. Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial. BMJ Open. 2022 Dec 7;12(12):e062211. doi: 10.1136/bmjopen-2022-062211.
- Individual participant dataSharing planned: No. If other researcher needs the IPD. Please contact songhang_pumch@163.com
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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.
Meifen Zhang, MD principal investigator
Peking Union Medical College Hospital
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 Adalimumab and Methotrexate in people with Uveitis, Anterior and Adalimumab, run by Peking Union Medical College Hospital 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 3 inclusion and 11 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
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 Hang Song, MD (+86 15600612346, songhang_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uveitis flare (time frame: At 6 months' follow-up visit). 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 NCT05015335, which also lists 5 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 10 Nov 2021.