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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Bilateral moderate to severe thyroid associated orbitopathy.
  2. Clinical Activity score (CAS) ≥ 3.
  3. Duration of thyroid associated orbitopathy < 2 years

Exclusion Criteria:

  1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
  2. Glaucoma patients or those known to be steroid responders
  3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
  4. Pregnancy
  5. Previous orbital or lid surgeries
  6. 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

First Posted
June 18, 2022
Last Updated
September 17, 2022
Sponsor
Cairo University
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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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