A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Seco… (NCT06176963) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO
Poland34 participantsStarted 2023-11-21
Plain-language summary
This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Neovascular AMD or macular oedema secondary to RVO in the study eye
* Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the ophthalmologist (e.g., retina specialist)
* Aged 18 years and older at the time of signing the informed consent form (ICF)
* Written ICF must be obtained from the subject prior to any study-related procedure (if the subject cannot read ICF, an impartial witness will be present during the entire informed consent discussion)
* Willingness and ability to undertake all scheduled visits and assessments
Exclusion Criteria:
* Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse \[i.e., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart\] in one or both eyes at Screening or at Day 1
* History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past ITV injections with any agent in either eye
* Active or suspected infectious disease, or active disorder that preclude safe use of IP at the discretion of the Investigator, in either eye or adnexa of either eye at Screening or at Day 1
* History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after ITV injection or intraocular procedures in either eye
* History of massive subconjunctiv…