Thyroid Eye DiseasePhase 2/3NCT04976816
Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease
A Phase 2/3 study testing peri-levator betamethasone injection, peri-levator triamcinolone injection and peri-levator and retrobulbar betamethasone injection in people with Thyroid Eye Disease, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of local injections of two different types of steroid (betamethasone suspension versus triamcinolone acetate) in management of patients with thyroid-related upper lid retraction either isolated or associated with proptosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- peri-levator betamethasone injection, peri-levator triamcinolone injection and peri-levator and retrobulbar betamethasone injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 30 Oct 2023
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Thyroid Eye Disease.
- Thyroid function within normal range.
Who cannot join
- Patients on systemic steroid and or immunosuppressive therapy.
- Patients underwent thyroidectomy.
- Sight threatening (severe) TED which requires immediate surgery.
- Patients with fibrotic ocular muscles who need surgery.
- Contraindications to steroid therapy as in pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis
To compare the efficacy of local injections of two different types of steroid (betamethasone suspension versus triamcinolone acetate) in management of patients with thyroid-related upper lid retraction either isolated or associated with proptosis.
Read the detailed description
Thyroid Eye Disease (TED) is a complex autoimmune disorder that causes substantial morbidity. It can result in enlargement and scarring of orbital fat and muscles with orbital disfigurement, diplopia, and even vision loss. Although the disease is self-limited following an inflammatory phase of 12 - 18 months, its long-term changes to periocular tissues may have a significant effect on the quality of life, mental health, and socioeconomic status of patients.
Most patients with TED (>90%) have Graves' disease, which is an inflammatory autoimmune condition that is caused by thyrotropin (TSH) receptor autoantibodies. Graves' disease is common around the world and it mainly affects middle-aged women with an overall prevalence of 0.5%.
Several validated assessment scores are used to assess different components of the disease. The two main current TED classifications are from the European Group on Graves Orbitopathy (EUGOGO); and Vision, Inflammation, Strabismus, Appearance (VISA). EUGOGO has introduced one score for clinical activity (CAS) and one for severity "Clinical Severity Score" (CSS). The baseline CAS asses 7 subjective symptoms and inflammatory signs with 3 additional points in follow-up for increased proptosis, decreased ocular motility, or decreased visual acuity (the CAS 10- point scale). In comparison, CSS evaluates the magnitude of the exophthalmometer or proptosis values, lid retraction, diplopia grades, and corneal involvement.
Periorbital inflammation can cause swelling, fatty infiltration, and scarring of the eyelid muscles, resulting in eyelid retraction and upper scleral exposure, which are the most common clinical features of TED.
Several treatment options have been described for correction of eyelid retraction (ELR), including local steroid, Botox and filler injection, and surgeries in the fibrotic stage. Although surgical treatment remains an effective option, the outcomes may be unpredictable. In addition, there are some situations where surgery is inappropriate or contraindicated, where temporary or definitive measures are required during the active phase of the disease, or where patients may prefer less invasive options.
Systemic steroid therapy is a well-established form of immunosuppressive treatment for TED. There have been reports showing promising results with local steroid injection for the treatment of upper eyelid retraction (UER), There are also some reports about the retrobulbar and periocular injection of steroids for management of proptosis in TED.
- Conditions
- Thyroid Eye Disease
- Being tested
- peri-levator betamethasone injection, peri-levator triamcinolone injection, peri-levator and retrobulbar betamethasone injection, peri-levator and retrobulbar triamcinolone injection
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-levator betamethasone injectionProcedure or surgery
The injection dose was 1 ml of betamethasone suspension (1 ml contains 5 mg betamethasone dipropionate \&2 mg betamethasone sodium phosphate). The needle was introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where the injection was delivered. The injection was repeated every 4 weeks according to the clinical response up to 5 injections.
peri-levator triamcinolone injectionProcedure or surgery
The needle was introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where 1ml (40mg/ml) triamcinolone acetate was injected. The injection was repeated every 4 weeks according to the clinical response up to 5 injections.
peri-levator and retrobulbar betamethasone injectionProcedure or surgery
In addition to peri-levator betamethasone injection for UER, a retrobulbar injection for proptosis was given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
peri-levator and retrobulbar triamcinolone injectionProcedure or surgery
In addition to peri-levator triamcinolone injection for UER, a retrobulbar injection for proptosis was given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
| Study group | Role | What they receive |
|---|---|---|
| A1 peri-levator betamethasone injection | Experimental | patients with isolated thyroid-related upper lid retraction who will be given the Peri-levator injection of betamethasone suspension Receives: Procedure: peri-levator betamethasone injection |
| A2 Peri-levator triamcinolone acetate injection | Experimental | patients with isolated thyroid-related upper lid retraction who will be given Peri-levator injection of triamcinolone acetate Receives: Procedure: peri-levator triamcinolone injection |
| B1 Peri-levator and retrobulbar betamethasone injection | Experimental | patients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of betamethasone suspension Receives: Procedure: peri-levator and retrobulbar betamethasone injection |
| B2 Peri-levator and retrobulbar triamcinolone acetate injection | Experimental | patients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of triamcinolone acetate Receives: Procedure: peri-levator and retrobulbar triamcinolone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the change in MRD1 in mm using slit lamp biomicroscope in all groups after peri-levator injection of different types of steroid
The technique was considered; 1) Effective if the MRD1 reached the normal value< or= 4.5mm, 2) Partially effective if the MRD1 was improved but did not reach the normal values, 3) Ineffective if no improvement occured in MRD1
Measured: 2 minutes
to measure the change in proptosis in mm using Hertel's exophthalmometer in group B after retrobulbar injection of different types of steroid
The technique will be considered; 1) Effective if the reading of Hertel's exophthalmometer reached the normal value (16±2mm), 2) Partially effective if the proptosis was improved but did not reach the normal values, 3) Ineffective of no improvement occured in proptosis
Measured: 4 minutes
Secondary outcomes (1)
to document any change in size of superior rectus levator complex and other extra-ocular muscles
measuring size of superior rectus levator complex and other extra-ocular muscles before and after injections by orbital imaging techniques (CT or MRI).
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Dec 2021
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Abdelnaser, Assiut University
- Investigators
- Ahmed Abdelal, MD, Study chair, Assiut UniversityMohamed Shehata, MD, Study director, Assiut UniversitySalma Kedwany, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976816
- Sponsor's protocol ID
- LBVTIMTED
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Leo S, Lee SY, Braverman LE. Hyperthyroidism. Lancet. 2016 Aug 27;388(10047):906-918. doi: 10.1016/S0140-6736(16)00278-6. Epub 2016 Mar 30.
PubMed 27038492Taylor PN, Albrecht D, Scholz A, Gutierrez-Buey G, Lazarus JH, Dayan CM, Okosieme OE. Global epidemiology of hyperthyroidism and hypothyroidism. Nat Rev Endocrinol. 2018 May;14(5):301-316. doi: 10.1038/nrendo.2018.18. Epub 2018 Mar 23.
PubMed 29569622Bartalena L, Baldeschi L, Boboridis K, Eckstein A, Kahaly GJ, Marcocci C, Perros P, Salvi M, Wiersinga WM; European Group on Graves' Orbitopathy (EUGOGO). The 2016 European Thyroid Association/European Group on Graves' Orbitopathy Guidelines for the Management of Graves' Orbitopathy. Eur Thyroid J. 2016 Mar;5(1):9-26. doi: 10.1159/000443828. Epub 2016 Mar 2.
PubMed 27099835Kazim M, Gold KG. A review of surgical techniques to correct upper eyelid retraction associated with thyroid eye disease. Curr Opin Ophthalmol. 2011 Sep;22(5):391-3. doi: 10.1097/ICU.0b013e3283499433.
PubMed 21730842Xu D, Liu Y, Xu H, Li H. Repeated triamcinolone acetonide injection in the treatment of upper-lid retraction in patients with thyroid-associated ophthalmopathy. Can J Ophthalmol. 2012 Feb;47(1):34-41. doi: 10.1016/j.jcjo.2011.12.005.
PubMed 22333849Hamed-Azzam S, Mukari A, Feldman I, Saliba W, Jabaly-Habib H, Briscoe D. Fornix triamcinolone injection for thyroid orbitopathy. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):811-6. doi: 10.1007/s00417-015-2957-7. Epub 2015 Feb 12.
PubMed 25673253Joos ZP, Sullivan TJ. Peri-levator palpebrae superioris triamcinolone injection for the treatment of thyroid eye disease-associated upper eyelid retraction. Clin Exp Ophthalmol. 2017 Aug;45(6):651-652. doi: 10.1111/ceo.12939. Epub 2017 Mar 28. No abstract available.
PubMed 28248444Poonyathalang A, Preechawat P, Charoenkul W, Tangtrakul P. Retrobulbar injection of triamcinolone in thyroid associated orbitopathy. J Med Assoc Thai. 2005 Mar;88(3):345-9.
PubMed 15962642Bagheri A, Abbaszadeh M, Yazdani S. Intraorbital Steroid Injection for Active Thyroid Ophthalmopathy. J Ophthalmic Vis Res. 2020 Feb 2;15(1):69-77. doi: 10.18502/jovr.v15i1.5948. eCollection 2020 Jan-Mar.
PubMed 32095211Wang Y, Du B, Yang M, Zhu Y, He W. Peribulbar injection of glucocorticoids for thyroid-associated ophthalmopathy and factors affecting therapeutic effectiveness: A retrospective cohort study of 386 cases. Exp Ther Med. 2020 Sep;20(3):2031-2038. doi: 10.3892/etm.2020.8896. Epub 2020 Jun 17.
PubMed 32782513Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
PubMed 27797318
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis
- ClinicalTrials.gov ID
- NCT04976816
- Acronym / sponsor ID
- LBVTIMTED
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 26 Jul 2021 (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.
To compare the efficacy of local injections of two different types of steroid (betamethasone suspension versus triamcinolone acetate) in management of patients with thyroid-related upper lid retraction either isolated or associated with proptosis.
Detailed description
Thyroid Eye Disease (TED) is a complex autoimmune disorder that causes substantial morbidity. It can result in enlargement and scarring of orbital fat and muscles with orbital disfigurement, diplopia, and even vision loss. Although the disease is self-limited following an inflammatory phase of 12 - 18 months, its long-term changes to periocular tissues may have a significant effect on the quality of life, mental health, and socioeconomic status of patients.
Most patients with TED (>90%) have Graves' disease, which is an inflammatory autoimmune condition that is caused by thyrotropin (TSH) receptor autoantibodies. Graves' disease is common around the world and it mainly affects middle-aged women with an overall prevalence of 0.5%.
Several validated assessment scores are used to assess different components of the disease. The two main current TED classifications are from the European Group on Graves Orbitopathy (EUGOGO); and Vision, Inflammation, Strabismus, Appearance (VISA). EUGOGO has introduced one score for clinical activity (CAS) and one for severity "Clinical Severity Score" (CSS). The baseline CAS asses 7 subjective symptoms and inflammatory signs with 3 additional points in follow-up for increased proptosis, decreased ocular motility, or decreased visual acuity (the CAS 10- point scale). In comparison, CSS evaluates the magnitude of the exophthalmometer or proptosis values, lid retraction, diplopia grades, and corneal involvement.
Periorbital inflammation can cause swelling, fatty infiltration, and scarring of the eyelid muscles, resulting in eyelid retraction and upper scleral exposure, which are the most common clinical features of TED.
Several treatment options have been described for correction of eyelid retraction (ELR), including local steroid, Botox and filler injection, and surgeries in the fibrotic stage. Although surgical treatment remains an effective option, the outcomes may be unpredictable. In addition, there are some situations where surgery is inappropriate or contraindicated, where temporary or definitive measures are required during the active phase of the disease, or where patients may prefer less invasive options.
Systemic steroid therapy is a well-established form of immunosuppressive treatment for TED. There have been reports showing promising results with local steroid injection for the treatment of upper eyelid retraction (UER), There are also some reports about the retrobulbar and periocular injection of steroids for management of proptosis in TED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 peri-levator betamethasone injection | Experimental | Procedure: peri-levator betamethasone injectionpatients with isolated thyroid-related upper lid retraction who will be given the Peri-levator injection of betamethasone suspension |
| A2 Peri-levator triamcinolone acetate injection | Experimental | Procedure: peri-levator triamcinolone injectionpatients with isolated thyroid-related upper lid retraction who will be given Peri-levator injection of triamcinolone acetate |
| B1 Peri-levator and retrobulbar betamethasone injection | Experimental | Procedure: peri-levator and retrobulbar betamethasone injectionpatients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of betamethasone suspension |
| B2 Peri-levator and retrobulbar triamcinolone acetate injection | Experimental | Procedure: peri-levator and retrobulbar triamcinolone injectionpatients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of triamcinolone acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Thyroid Eye Disease.
- Thyroid function within normal range.
Key exclusion criteria (5 listed)
- Patients on systemic steroid and or immunosuppressive therapy.
- Patients underwent thyroidectomy.
- Sight threatening (severe) TED which requires immediate surgery.
- Patients with fibrotic ocular muscles who need surgery.
- Contraindications to steroid therapy as in pregnant women.
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 |
|---|---|---|
| peri-levator betamethasone injectionThe injection dose was 1 ml of betamethasone suspension (1 ml contains 5 mg betamethasone dipropionate \&2 mg betamethasone sodium phosphate). The needle was introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where the injection was delivered. The injection was repeated every 4 weeks according to the clinical response up to 5 injections. | Procedure or surgery | A1 peri-levator betamethasone injection |
| peri-levator triamcinolone injectionThe needle was introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where 1ml (40mg/ml) triamcinolone acetate was injected. The injection was repeated every 4 weeks according to the clinical response up to 5 injections. | Procedure or surgery | A2 Peri-levator triamcinolone acetate injection |
| peri-levator and retrobulbar betamethasone injectionIn addition to peri-levator betamethasone injection for UER, a retrobulbar injection for proptosis was given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space. | Procedure or surgery | B1 Peri-levator and retrobulbar betamethasone injection |
| peri-levator and retrobulbar triamcinolone injectionIn addition to peri-levator triamcinolone injection for UER, a retrobulbar injection for proptosis was given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space. | Procedure or surgery | B2 Peri-levator and retrobulbar triamcinolone acetate injection |
Primary outcome
to measure the change in MRD1 in mm using slit lamp biomicroscope in all groups after peri-levator injection of different types of steroid
Time frame: 2 minutes
The technique was considered; 1) Effective if the MRD1 reached the normal value< or= 4.5mm, 2) Partially effective if the MRD1 was improved but did not reach the normal values, 3) Ineffective if no improvement occured in MRD1
to measure the change in proptosis in mm using Hertel's exophthalmometer in group B after retrobulbar injection of different types of steroid
Time frame: 4 minutes
The technique will be considered; 1) Effective if the reading of Hertel's exophthalmometer reached the normal value (16±2mm), 2) Partially effective if the proptosis was improved but did not reach the normal values, 3) Ineffective of no improvement occured in proptosis
1 secondary outcome
to document any change in size of superior rectus levator complex and other extra-ocular muscles
Time frame: 4 minutes
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 14 Nov 2023.
- Background: PubMed 27038492De Leo S, Lee SY, Braverman LE. Hyperthyroidism. Lancet. 2016 Aug 27;388(10047):906-918. doi: 10.1016/S0140-6736(16)00278-6. Epub 2016 Mar 30.
- Background: PubMed 29569622Taylor PN, Albrecht D, Scholz A, Gutierrez-Buey G, Lazarus JH, Dayan CM, Okosieme OE. Global epidemiology of hyperthyroidism and hypothyroidism. Nat Rev Endocrinol. 2018 May;14(5):301-316. doi: 10.1038/nrendo.2018.18. Epub 2018 Mar 23.
- Background: PubMed 27099835Bartalena L, Baldeschi L, Boboridis K, Eckstein A, Kahaly GJ, Marcocci C, Perros P, Salvi M, Wiersinga WM; European Group on Graves' Orbitopathy (EUGOGO). The 2016 European Thyroid Association/European Group on Graves' Orbitopathy Guidelines for the Management of Graves' Orbitopathy. Eur Thyroid J. 2016 Mar;5(1):9-26. doi: 10.1159/000443828. Epub 2016 Mar 2.
- Background: PubMed 21730842Kazim M, Gold KG. A review of surgical techniques to correct upper eyelid retraction associated with thyroid eye disease. Curr Opin Ophthalmol. 2011 Sep;22(5):391-3. doi: 10.1097/ICU.0b013e3283499433.
- Background: PubMed 22333849Xu D, Liu Y, Xu H, Li H. Repeated triamcinolone acetonide injection in the treatment of upper-lid retraction in patients with thyroid-associated ophthalmopathy. Can J Ophthalmol. 2012 Feb;47(1):34-41. doi: 10.1016/j.jcjo.2011.12.005.
- Background: PubMed 25673253Hamed-Azzam S, Mukari A, Feldman I, Saliba W, Jabaly-Habib H, Briscoe D. Fornix triamcinolone injection for thyroid orbitopathy. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):811-6. doi: 10.1007/s00417-015-2957-7. Epub 2015 Feb 12.
- Background: PubMed 28248444Joos ZP, Sullivan TJ. Peri-levator palpebrae superioris triamcinolone injection for the treatment of thyroid eye disease-associated upper eyelid retraction. Clin Exp Ophthalmol. 2017 Aug;45(6):651-652. doi: 10.1111/ceo.12939. Epub 2017 Mar 28. No abstract available.
- Background: PubMed 15962642Poonyathalang A, Preechawat P, Charoenkul W, Tangtrakul P. Retrobulbar injection of triamcinolone in thyroid associated orbitopathy. J Med Assoc Thai. 2005 Mar;88(3):345-9.
- Background: PubMed 32095211Bagheri A, Abbaszadeh M, Yazdani S. Intraorbital Steroid Injection for Active Thyroid Ophthalmopathy. J Ophthalmic Vis Res. 2020 Feb 2;15(1):69-77. doi: 10.18502/jovr.v15i1.5948. eCollection 2020 Jan-Mar.
- Background: PubMed 32782513Wang Y, Du B, Yang M, Zhu Y, He W. Peribulbar injection of glucocorticoids for thyroid-associated ophthalmopathy and factors affecting therapeutic effectiveness: A retrospective cohort study of 386 cases. Exp Ther Med. 2020 Sep;20(3):2031-2038. doi: 10.3892/etm.2020.8896. Epub 2020 Jun 17.
- Results publication: PubMed 27797318Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
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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.
Ahmed Abdelal, MD study chair
Assiut University
Mohamed Shehata, MD study director
Assiut University
Salma Kedwany, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing peri-levator betamethasone injection, peri-levator triamcinolone injection and peri-levator and retrobulbar betamethasone injection in people with Thyroid Eye Disease, run by Assiut 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 2 inclusion and 5 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 14 Nov 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
to measure the change in MRD1 in mm using slit lamp biomicroscope in all groups after peri-levator injection of different types of steroid (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04976816, which also lists 11 linked publications.
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 14 Nov 2023.