Back to resultsA Clinical Trial of Infliximab for Childhood Uveitis
Primary Purpose
Uveitis, Infliximab
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Childhood Uveitis
Arm Description
5mg/kg/dose of infliximab IV initially two weeks, then 4 weeks and then every 6-8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04150770
Brief Title
A Clinical Trial of Infliximab for Childhood Uveitis
Official Title
A Clinical Trial of Infliximab for Injection in Refractory Childhood Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaomin Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Infliximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Childhood Uveitis
Arm Type
Experimental
Arm Description
5mg/kg/dose of infliximab IV initially two weeks, then 4 weeks and then every 6-8 weeks
Intervention Type
Drug
Intervention Name(s)
infliximab
Other Intervention Name(s)
Remicade
Primary Outcome Measure Information:
Title
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit.
Description
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.
Time Frame
24 weeks
Title
Change in Vitreous Haze (VH) Grade From Baseline to Each Visit.
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomin Zhang, M.D.
Organizational Affiliation
Tianjin Medical University Eye Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol, statistical analysis plan and informed Consent form can be shared with other researchers.
Learn more about this trial
A Clinical Trial of Infliximab for Childhood Uveitis
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