UveitisPhase 4NCT04150770
A Clinical Trial of Infliximab for Childhood Uveitis
A Phase 4 study testing infliximab in people with Uveitis and Infliximab, run by Xiaomin Zhang.
Trial summary
This project is designed to test the hypothesis that infliximab is clinically useful for patients with refractory childhood uveitis. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Uveitis, Infliximab
- What is being tested?
- infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2022
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 4 to 18 years old,
- Non-infectious uveitis
- Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
- Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
- Ability to provide informed consent (subject or parent/guardian)
- Onset of uveitis < 16 years of age.
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- Topical ophthalmologic treatments allowed.
- Systemic corticosteroid use at entry may be allowed.
- Participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination.
- Negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab
- The screening laboratory test results must meet the following criteria:
- WBC (white blood cell count): within normal range for institution ANC (absolute neutrophil count): within normal range for institution Hemoglobin: greater than 10 grams/deciliter Platelets: within normal range for institution Serum Creatinine: within normal range for age AST - aspartate aminotransferase - within normal range for institution ALT - alanine aminotransferase- within normal range for institution
Who cannot join
- Previous use of biologic medications for uveitis.
- Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
- Uveitis due to trauma or intraocular surgery
- A history of a known allergy to murine products.
- Documentation of seropositivity for human immunodeficiency virus (HIV).
- Documentation of a positive test for hepatitis B surface antigen or hepatitis C
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- A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
- An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- A concomitant diagnosis or history of congestive heart failure.
- A history of lymphoproliferative disease.
- Any known malignancy or a history of malignancy.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- Use of any investigational drug within 30 days prior to screening or within five half-lives of the first dose of the investigational agent, whichever is longer.
- Presence of a transplanted solid organ.
About this study
Official title: A Clinical Trial of Infliximab for Injection in Refractory Childhood Uveitis
This project is designed to test the hypothesis that infliximab is clinically useful for patients with refractory childhood uveitis.
Read the detailed description
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the study design, aims, and the off-label use of infliximab, its potential risks and benefits. This is a prospective non-comparative interventional study.
Participants will receive intravitreal injections of suggested dose of infliximab (5 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.
- Conditions
- Uveitis, Infliximab
- Being tested
- infliximab
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabDrug
Also called Remicade
| Study group | Role | What they receive |
|---|---|---|
| Patients with Childhood Uveitis | Experimental | 5mg/kg/dose of infliximab IV initially two weeks, then 4 weeks and then every 6-8 weeks Receives: Drug: infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
Participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Measured: 24 weeks
Secondary outcomes (2)
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit.
Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:
Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells.
Measured: 24 weeks
Change in Vitreous Haze (VH) Grade From Baseline to Each Visit.
Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:
Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startJan 2017
- Primary completionJan 2020
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaomin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaomin Zhang, Tianjin Medical University
- Investigators
- Xiaomin Zhang, M.D., Study director, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150770
- Sponsor's protocol ID
- 2017KY-05
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2019
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No: Study protocol, statistical analysis plan and informed Consent form can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Infliximab for Injection in Refractory Childhood Uveitis
- ClinicalTrials.gov ID
- NCT04150770
- Acronym / sponsor ID
- 2017KY-05
- Conditions
- Uveitis, Infliximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xiaomin ZhangUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Nov 2019 (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.
This project is designed to test the hypothesis that infliximab is clinically useful for patients with refractory childhood uveitis.
Detailed description
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the study design, aims, and the off-label use of infliximab, its potential risks and benefits. This is a prospective non-comparative interventional study.
Participants will receive intravitreal injections of suggested dose of infliximab (5 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Childhood Uveitis | Experimental | Drug: infliximab5mg/kg/dose of infliximab IV initially two weeks, then 4 weeks and then every 6-8 weeks |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Ages 4 to 18 years old,
- Non-infectious uveitis
- Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
- Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
- Ability to provide informed consent (subject or parent/guardian)
Key exclusion criteria (14 listed)
- Previous use of biologic medications for uveitis.
- Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
- Uveitis due to trauma or intraocular surgery
- A history of a known allergy to murine products.
- Documentation of seropositivity for human immunodeficiency virus (HIV).
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 |
|---|---|---|
| infliximabAlso: Remicade | Drug | Patients with Childhood Uveitis |
Primary outcome
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
Time frame: 24 weeks
Participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
2 secondary outcomes
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit.
Time frame: 24 weeks
Change in Vitreous Haze (VH) Grade From Baseline to Each Visit.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: No. Study protocol, statistical analysis plan and informed Consent form can be shared with other researchers.
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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.
Xiaomin Zhang, M.D. study director
Tianjin Medical University Eye Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infliximab in people with Uveitis and Infliximab, run by Xiaomin Zhang.
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 12 inclusion and 14 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 2 Nov 2021. 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 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?
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?
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2021.