13 Clinical Trials Summary
13.0 Introduction
13.1 Cornea
13.2 Cataract
13.3 Medical Retina – Age-Related Macular Degeneration (AMD)
13.4 Medical Retina - Diabetes
13.5 Medical Retina – Retinal Vein Occlusion (RVO)
13.6 Vitreoretinal Surgery
13.7 Glaucoma
13.8 Oculoplastics
13.9 Paediatrics
13.10 Neuro-Ophthalmology
13.11 Ocular Oncology
13.8 Oculoplastics
TED = thyroid eye disease; IVMP = intravenous methylprednisolone
EUGOGO [lxxxiii]
Consensus guidelines for TED treatment with corticosteroids
Key Points
- Treat active TED (CAS ≥ 4) with IVMP:
- 500mg weekly for 6 weeks, then 250mg weekly for 6 weeks
- Treat sight-threatening TED (optic neuropathy or corneal exposure) with IVMP:
- 1g daily for 3 days
- Lifetime cumulative IVMP dose should not exceed 8g
- Risk of fatal hepatotoxicity
- Risk of fatal hepatotoxicity
Risk Factors
- Key risk factors for poor disease control:
- Cigarette smoking
- Poor TFT control
- Radioactive iodine precipitates active TED
Bartalena, L., Baldeschi, L., Dickinson, A.J. et al. 2008. Consensus statement of the European group on Graves' orbitopathy (EUGOGO) on management of Graves' orbitopathy. Thyroid 18(3) 333-346.
OPTIC [lxxxiv]
P3 trial - teprotumomab for active TED
Teprotumomab effective for treatment of active TED compared to placebo, (reducing proptosis, diplopia and clinical activity and improving QOL). Safe
No comparison made with IVMP
Douglas, R.S., Kahaly, G.J., Patel, A. et al. 2020. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med 382(4) 341-352.
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13.9 Paediatrics
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