A pilot study towards a therapy with prednisolone encapsulated liposomes for the treatment of Graves' Orbitopathy with reduced systemic steroid exposure
- Conditions
- Active GO (CAS 3 𔂻).
- Registration Number
- NL-OMON24926
- Lead Sponsor
- Het Oogziekenhuis Rotterdam /Rotterdam Ophthalmic Institute<br>PO Box 70030, NL-3000 LM Rotterdam<br>Telephone: +31 (0) 10 4023 449
- Brief Summary
Paridaens D, Detiger SE, Kremer T, Dalm VASH, de Keizer ROB, Dik WA, Wubbels R, Peeters RP. Nanocort in the medical treatment of moderate-to-severe Graves’ orbitopathy: A pilot study. Acta Ophthalmol. 2020; 98(Suppl. S264): 10. [Abstract] Detiger SE, Kremer TM, Dalm VASH, de Keizer ROB, Wubbels RJ, Metselaar JM, van Hagen PM, Peeters RP, Paridaens D. A pilot study on the use of prednisolone encapsulated liposomes for the treatment of moderate-to-severe Graves’ orbitopathy with reduced systemic steroid exposure. Acta Ophthalmol, 2021; 99: 797-804. PMID: 33423386
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Male or female ≥ 18 years old.
2. Informed consent.
1. Sight threatening GO due to optic neuropathy (decrease of (pinhole) vision, visual field loss, prolonged VEP, diminished colour vision) or severe keratopathy.
2. Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method