An interventional study of Betamethasone in Thyroid Eye Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
198 studies on the registry are indexed under Graves Ophthalmopathy; 60 are open to participants now.
This study's planned enrollment of 54 is below the median of 64 across 147 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Perilevator betamethasone injection delivered via the transconjunctival (subconjunctival/retro-septal) approach.
Drug: Betamethasone
Perilevator betamethasone injection delivered via the transcutaneous (percutaneous para-levator) approach.
Drug: Betamethasone
Betamethasone suspension 1 mL injected into the perilevator space.
Also known as: Celestone
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.
Time frame: At 3 months
Proportion of eyes with effective response
Proportion of eyes achieving MRD1 ≤ 4.5 mm at 3 months.
Time frame: At 3 months
Mean number of injections required
Mean number of betamethasone injections required to reach target MRD1.
Time frame: At 12 months
Proportion of eyes with intraocular pressure elevation
Proportion of eyes with intraocular pressure ≥ 21 mmHg or increase ≥ 5 mmHg from baseline.
Time frame: At 12 months
Change in Graefe sign
Mean change in lid lag on downgaze (Graefe sign) in millimeters from baseline to 3 months.
Time frame: At 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Betamethasone