NL-OMON24926
Completed
Not Applicable
A pilot study towards a therapy with prednisolone encapsulated liposomes for the treatment of Graves¡¯ Orbitopathy with reduced systemic steroid exposure
Het Oogziekenhuis Rotterdam /Rotterdam Ophthalmic Institute<br>PO Box 70030, NL-3000 LM Rotterdam<br>Telephone: +31 (0) 10 4023 4490 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Active GO (CAS 3 ‒
- Sponsor
- Het Oogziekenhuis Rotterdam /Rotterdam Ophthalmic Institute<br>PO Box 70030, NL-3000 LM Rotterdam<br>Telephone: +31 (0) 10 4023 449
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female ≥ 18 years old.
- •2\. Informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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