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ASEDs for severe ocular chronic GVHD
NCT01972438Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2013
- Primary completion
- May 2015
- Countries
- 1
- Sponsor
- National Eye Institute
- Modality
- Biologic, NPI (Non-Pharmacological Intervention)
- Conditions
- graft versus host disease (GVHD)
01
Overview
Phase 2, randomised, double-blind trial of autologous serum artificial tears in graft versus host disease (GVHD), sponsored by National Eye Institute. Primary endpoint: Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale… at 3 months. Started Nov 2013; status: terminated.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults with severe ocular GVHD unresponsive to standard medical treatment for at least 3 months, with specific keratopathy and Schirmer test scores.
04
Endpoints
Primary
Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale…
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