Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease

November 10, 2023 updated by: Rawda Abdelnaser, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1 peri-levator betamethasone injection
patients with isolated thyroid-related upper lid retraction who will be given the Peri-levator injection of betamethasone suspension
Procedure: peri-levator betamethasone injection
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.
Experimental: A2 Peri-levator triamcinolone acetate injection
patients with isolated thyroid-related upper lid retraction who will be given Peri-levator injection of triamcinolone acetate
Procedure: peri-levator triamcinolone injection
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.
Experimental: B1 Peri-levator and retrobulbar betamethasone injection
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
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.
Experimental: B2 Peri-levator and retrobulbar triamcinolone acetate injection
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
4 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to document any change in size of superior rectus levator complex and other extra-ocular muscles
Time Frame: 4 minutes
measuring size of superior rectus levator complex and other extra-ocular muscles before and after injections by orbital imaging techniques (CT or MRI).
4 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ahmed Abdelal, MD, Assiut University
  • Study Director: Mohamed Shehata, MD, Assiut University
  • Study Director: Salma Kedwany, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBVTIMTED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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