Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease

NCT04976816 | Completed Phase 2

• 1 other identifier: LBVTIMTED
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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

  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

  4 minutes

Secondary Outcomes (1)

• to document any change in size of superior rectus levator complex and other extra-ocular muscles

  4 minutes

Study Arms (4)

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

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

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

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

Procedure: peri-levator and retrobulbar triamcinolone injection

Interventions

peri-levator betamethasone injection PROCEDURE

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.

A1 peri-levator betamethasone injection

peri-levator triamcinolone injection PROCEDURE

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.

A2 Peri-levator triamcinolone acetate injection

peri-levator and retrobulbar betamethasone injection PROCEDURE

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.

B1 Peri-levator and retrobulbar betamethasone injection

peri-levator and retrobulbar triamcinolone injection PROCEDURE

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.

B2 Peri-levator and retrobulbar triamcinolone acetate injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Thyroid Eye Disease.
• Thyroid function within normal range.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (11)

• 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.

  PMID: 27038492 BACKGROUND

• Taylor 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.

  PMID: 29569622 BACKGROUND

• Bartalena 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.

  PMID: 27099835 BACKGROUND

• Kazim 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.

  PMID: 21730842 BACKGROUND

• Xu 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.

  PMID: 22333849 BACKGROUND

• Hamed-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.

  PMID: 25673253 BACKGROUND

• Joos 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.

  PMID: 28248444 BACKGROUND

• Poonyathalang 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.

  PMID: 15962642 BACKGROUND

• Bagheri 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.

  PMID: 32095211 BACKGROUND

• Wang 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.

  PMID: 32782513 BACKGROUND

• Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.

  PMID: 27797318 RESULT

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ahmed Abdelal, MD

  Assiut University

  STUDY CHAIR

• Mohamed Shehata, MD

  Assiut University

  STUDY DIRECTOR

• Salma Kedwany, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 26, 2021
• Study Start: December 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

EG (1)