Thyroid Eye DiseaseNCT07866261
Transconjunctival Versus Transcutaneous Betamethasone for Upper Eyelid Retraction in TED
A study testing Betamethasone in people with Thyroid Eye Disease, run by Assiut University.
Trial summary
This randomized controlled trial aims to compare the efficacy and safety of transconjunctival versus transcutaneous perilevator betamethasone injection in reducing upper eyelid retraction in patients with thyroid eye disease. 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?
- Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- - Age 18 years or older
- Clinical diagnosis of thyroid eye disease with stable thyroid function for at least 3 months
- Unilateral or bilateral upper eyelid retraction with Margin Reflex Distance 1 greater than 4.5 mm in at least one eye
- Thyroid eye disease duration less than 24 months
- Written informed consent
Who cannot join
- - Active sight-threatening thyroid eye disease requiring urgent decompression or systemic immunosuppression
- Current or recent (within 3 months) systemic corticosteroids or other immunosuppressives for thyroid eye disease
- Previous levator or Müller muscle surgery, botulinum toxin, or filler injection to the upper eyelid within 6 months
- Contraindications to local steroid injection (active ocular infection, uncontrolled glaucoma, pregnancy or lactation)
- Significant corneal exposure keratopathy requiring immediate surgical intervention
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transconjunctival Versus Transcutaneous Perilevator Betamethasone Injection for the Management of Thyroid Eye Disease-Related Upper Eyelid Retraction
This randomized controlled trial aims to compare the efficacy and safety of transconjunctival versus transcutaneous perilevator betamethasone injection in reducing upper eyelid retraction in patients with thyroid eye disease.
Read the detailed description
Thyroid eye disease is an autoimmune orbital disorder that frequently causes upper eyelid retraction. Local corticosteroid injection around the levator-Müller complex is a minimally invasive treatment option.
This prospective randomized double-blind parallel-group trial will compare two injection approaches (transconjunctival versus transcutaneous) of betamethasone in adult patients with thyroid eye disease-related upper eyelid retraction. The primary outcome is the change in Margin Reflex Distance 1 (MRD1) at 3 months after the first injection.
- Conditions
- Thyroid Eye Disease
- Being tested
- Betamethasone
- Keywords
- Transconjunctival, Thyroid eye disease, Betamethasone, Upper eyelid retraction, Transcutaneous, Perilevator injection, Assiut
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called Celestone
Betamethasone suspension 1 mL injected into the perilevator space.
| Study group | Role | What they receive |
|---|---|---|
| Transconjunctival Perilevator Injection | Experimental | Perilevator betamethasone injection delivered via the transconjunctival (subconjunctival/retro-septal) approach. Receives: Drug: Betamethasone |
| Transcutaneous Perilevator Injection | Active comparator | Perilevator betamethasone injection delivered via the transcutaneous (percutaneous para-levator) approach. Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Margin Reflex Distance 1
Mean change in Margin Reflex Distance 1 (MRD1) in millimeters from baseline to 3 months after the first injection.
Measured: At 3 months
Secondary outcomes (4)
Proportion of eyes with effective response
Proportion of eyes achieving MRD1 ≤ 4.5 mm at 3 months.
Measured: At 3 months
Mean number of injections required
Mean number of betamethasone injections required to reach target MRD1.
Measured: At 12 months
Proportion of eyes with intraocular pressure elevation
Proportion of eyes with intraocular pressure ≥ 21 mmHg or increase ≥ 5 mmHg from baseline.
Measured: At 12 months
Change in Graefe sign
Mean change in lid lag on downgaze (Graefe sign) in millimeters from baseline to 3 months.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Nashaat, Assiut University
- Investigators
- Abdelnasser m Awad, prof, Study chair, Ophthalmology Department, Assiut University HospitalsSarah H Alataar, Prof, Study chair, Ophthalmology Department,Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866261
- Sponsor's protocol ID
- TED-Betamethasone-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transconjunctival Versus Transcutaneous Perilevator Betamethasone Injection for the Management of Thyroid Eye Disease-Related Upper Eyelid Retraction
- ClinicalTrials.gov ID
- NCT07866261
- Acronym / sponsor ID
- TED-Betamethasone-Assiut-2026
- Conditions
- Thyroid Eye Disease
- Keywords
- Transconjunctival, Thyroid eye disease, Betamethasone, Upper eyelid retraction, Transcutaneous, Perilevator injection, Assiut
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 8 Oct 2026 (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.
This randomized controlled trial aims to compare the efficacy and safety of transconjunctival versus transcutaneous perilevator betamethasone injection in reducing upper eyelid retraction in patients with thyroid eye disease.
Detailed description
Thyroid eye disease is an autoimmune orbital disorder that frequently causes upper eyelid retraction. Local corticosteroid injection around the levator-Müller complex is a minimally invasive treatment option.
This prospective randomized double-blind parallel-group trial will compare two injection approaches (transconjunctival versus transcutaneous) of betamethasone in adult patients with thyroid eye disease-related upper eyelid retraction. The primary outcome is the change in Margin Reflex Distance 1 (MRD1) at 3 months after the first 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 |
|---|---|---|
| Transconjunctival Perilevator Injection | Experimental | Drug: BetamethasonePerilevator betamethasone injection delivered via the transconjunctival (subconjunctival/retro-septal) approach. |
| Transcutaneous Perilevator Injection | Active comparator | Drug: BetamethasonePerilevator betamethasone injection delivered via the transcutaneous (percutaneous para-levator) approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Age 18 years or older
- Clinical diagnosis of thyroid eye disease with stable thyroid function for at least 3 months
- Unilateral or bilateral upper eyelid retraction with Margin Reflex Distance 1 greater than 4.5 mm in at least one eye
- Thyroid eye disease duration less than 24 months
- Written informed consent
Key exclusion criteria (5 listed)
- - Active sight-threatening thyroid eye disease requiring urgent decompression or systemic immunosuppression
- Current or recent (within 3 months) systemic corticosteroids or other immunosuppressives for thyroid eye disease
- Previous levator or Müller muscle surgery, botulinum toxin, or filler injection to the upper eyelid within 6 months
- Contraindications to local steroid injection (active ocular infection, uncontrolled glaucoma, pregnancy or lactation)
- Significant corneal exposure keratopathy requiring immediate surgical intervention
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 |
|---|---|---|
| BetamethasoneAlso: CelestoneBetamethasone suspension 1 mL injected into the perilevator space. | Drug | Transconjunctival Perilevator Injection, Transcutaneous Perilevator Injection |
Primary outcome
Change in Margin Reflex Distance 1
Time frame: At 3 months
Mean change in Margin Reflex Distance 1 (MRD1) in millimeters from baseline to 3 months after the first injection.
4 secondary outcomes
Proportion of eyes with effective response
Time frame: At 3 months
Mean number of injections required
Time frame: At 12 months
Proportion of eyes with intraocular pressure elevation
Time frame: At 12 months
Change in Graefe sign
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Abdelnasser m Awad, prof study chair
Ophthalmology Department, Assiut University Hospitals
Sarah H Alataar, Prof study chair
Ophthalmology Department,Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone in people with Thyroid Eye Disease, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba A Nashat, Resident (+20 10 27021038, Heba.nashaat6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Margin Reflex Distance 1 (time frame: At 3 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 8 Oct 2026.