Thyroid Associated OrbitopathyPhase 2TOMATONCT05429450
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
A Phase 2 study testing Methotrexate and Triamcinolone Acetonide in people with Thyroid Associated Orbitopathy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Associated Orbitopathy
- What is being tested?
- Methotrexate and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 15 Jul 2022
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bilateral moderate to severe thyroid associated orbitopathy.
- Clinical Activity score (CAS) ≥ 3.
- Duration of thyroid associated orbitopathy < 2 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy
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.
Read the 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
- Conditions
- Thyroid Associated Orbitopathy
- Being tested
- Methotrexate, Triamcinolone Acetonide
- Keywords
- Thyroid associated orbitopathy, Grave's orbitopathy, Periocular injections, Methotrexate, Triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Three periocular injections of methotrexate at week 0, week 3 and week 6.
Triamcinolone AcetonideDrug
Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Periocular injections of methotrexate Receives: Drug: Methotrexate |
| Triamcinolone acetonide | Active comparator | Periocular injections of triamcinolone acetonide Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 1 month, 3 months and 6 months
Secondary outcomes (3)
Change in proptosis
Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis
Measured: 2 weeks, 1 month, 3 months and 6 months
Change in lid aperture
Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler
Measured: 2 weeks, 1 month, 3 months and 6 months
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
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jul 2020
- Primary completion1 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Associated OrbitopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Youssef Swaify, Cairo University
- Investigators
- Haytham E. Nasr, Study chair, Cairo UniversityRania A. El Essawy, Study director, Cairo UniversityKareem B. Elessawy, Study director, Cairo UniversityIslam Y. Swaify, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429450
- Sponsor's protocol ID
- MD-139-2020
- Acronym
- TOMATO
- Status last verified
- Sep 2022
- First submitted
- 18 Jun 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy
- ClinicalTrials.gov ID
- NCT05429450
- Acronym / sponsor ID
- TOMATO / MD-139-2020
- Conditions
- Thyroid Associated Orbitopathy
- Keywords
- Thyroid associated orbitopathy, Grave's orbitopathy, Periocular injections, Methotrexate, Triamcinolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 23 Jun 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: MethotrexatePeriocular injections of methotrexate |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone AcetonidePeriocular injections of triamcinolone acetonide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Bilateral moderate to severe thyroid associated orbitopathy.
- Clinical Activity score (CAS) ≥ 3.
- Duration of thyroid associated orbitopathy < 2 years
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| MethotrexateThree periocular injections of methotrexate at week 0, week 3 and week 6. | Drug | Methotrexate |
| Triamcinolone AcetonideThree periocular injections of triamcinolone acetonide at week 0, week 3 and week 6. | Drug | Triamcinolone acetonide |
Primary outcome
Change in clinical activity score (CAS)
Time frame: 2 weeks, 1 month, 3 months and 6 months
Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is >3.
3 secondary outcomes
Change in proptosis
Time frame: 2 weeks, 1 month, 3 months and 6 months
Change in lid aperture
Time frame: 2 weeks, 1 month, 3 months and 6 months
Percentage of overall responders
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Haytham E. Nasr study chair
Cairo University
Rania A. El Essawy study director
Cairo University
Kareem B. Elessawy study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate and Triamcinolone Acetonide in people with Thyroid Associated Orbitopathy, run by Cairo University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 21 Sep 2022. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 clinical activity score (CAS) (time frame: 2 weeks, 1 month, 3 months and 6 months). 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 21 Sep 2022.