Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections (TOMATO)
Primary Purpose
Thyroid Associated Orbitopathy
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Methotrexate
Triamcinolone Acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Associated Orbitopathy focused on measuring Thyroid associated orbitopathy, Grave's orbitopathy, Periocular injections, Methotrexate, Triamcinolone
Eligibility Criteria
Inclusion Criteria:
- Bilateral moderate to severe thyroid associated orbitopathy.
- Clinical Activity score (CAS) ≥ 3.
- Duration of thyroid associated orbitopathy < 2 years
Exclusion Criteria:
- Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
- Glaucoma patients or those known to be steroid responders
- Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
- Pregnancy
- Previous orbital or lid surgeries
- History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methotrexate
Triamcinolone acetonide
Arm Description
Periocular injections of methotrexate
Periocular injections of triamcinolone acetonide
Outcomes
Primary Outcome Measures
Change in clinical activity score (CAS)
Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is >3.
Secondary Outcome Measures
Change in proptosis
Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis
Change in lid aperture
Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler
Percentage of overall responders
A participant is considered an overall responder if 2 or more of the following:
Improvement of CAS ≥ 2 points.
Improvement of proptosis ≥ 2 mm.
Improvement of lid aperture ≥ 2 mm.
Improvement of soft tissue signs ≥ 1 grade
Improvement of EOM ductions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05429450
Brief Title
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
Acronym
TOMATO
Official Title
Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.
Detailed Description
Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Orbitopathy
Keywords
Thyroid associated orbitopathy, Grave's orbitopathy, Periocular injections, Methotrexate, Triamcinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate
Arm Type
Experimental
Arm Description
Periocular injections of methotrexate
Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
Periocular injections of triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Three periocular injections of methotrexate at week 0, week 3 and week 6.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.
Primary Outcome Measure Information:
Title
Change in clinical activity score (CAS)
Description
Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is >3.
Time Frame
2 weeks, 1 month, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Change in proptosis
Description
Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis
Time Frame
2 weeks, 1 month, 3 months and 6 months
Title
Change in lid aperture
Description
Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler
Time Frame
2 weeks, 1 month, 3 months and 6 months
Title
Percentage of overall responders
Description
A participant is considered an overall responder if 2 or more of the following:
Improvement of CAS ≥ 2 points.
Improvement of proptosis ≥ 2 mm.
Improvement of lid aperture ≥ 2 mm.
Improvement of soft tissue signs ≥ 1 grade
Improvement of EOM ductions
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral moderate to severe thyroid associated orbitopathy.
Clinical Activity score (CAS) ≥ 3.
Duration of thyroid associated orbitopathy < 2 years
Exclusion Criteria:
Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
Glaucoma patients or those known to be steroid responders
Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
Pregnancy
Previous orbital or lid surgeries
History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haytham E. Nasr
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rania A. El Essawy
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kareem B. Elessawy
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Islam Y. Swaify
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
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