Do the Repackaged Bevacizumab for Intravitreal Administration still have the same Sterility Stability and Efficacy at Day 0 Day 14 Day 30 after storage Do the Repackaged Aflibercept for Intravitreal Administration still have the same Sterility Stability and Efficacy at Day 0 Day 14 Day 30 after storage Do the Repackaged Ranibizumab for Intravitreal Administration still have the same Sterility Stability and Efficacy at Day 0 Day 14 Day 30 after storage Do the Repackaged Brolucizumab for Int
Conditions
Interventions
Evaluate 1. physical properties: Size exclusion chromatography (SEC), 2. Functional efficacy: enzyme-linked immunosorbent assay (ELISA) to assess, Sterility testing: bacterial culturing and PCR ,Evalu
Bevacizumab,Aflibercept,Ranibizumab,Brolucizumab,Faricimab
Sponsors
Ophthalmology Department, Faculty of medicine Ramathibodi hospital , Mahidol University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with any retinal disease that receive Anti VEGF include Bevacizumab, Aflibercept, Ranibizumab, Brolucizumab, and Faricimab.
Exclusion criteria
Exclusion criteria: Other Patient with any retinal disease that receive other IVT agents apart from Bevacizumab, Aflibercept, Ranibizumab, Brolucizumab, and Faricimab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate protein concentration(Physical properties): Size exclusion chromatography, Protein-binding property (Functional efficacy): ELISA, Sterility testing: Culture plate Day 0, 14, 30 after repacked the drug Mann-Whitney U tests was used to compare protein concentrations, drug efficacy. Area under th curve: Drug concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/A N/A | — |
Countries
Thailand
Contacts
Public ContactChaiyawat Tonawannakorn
Faculty of medicine Ramathibodi hospital , Mahidol University
Outcome results
None listed