Clareo Health | A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)
A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ocular
Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist
You may not be if
Concurrent Ocular Conditions
Patients legally blind in one or both eyes
History of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction (any grading from trace and greater is excluded), including non-infectious uveitis or uveitis, or sterile inflammatory reaction after the past ITV injections with any agent
Active disorder of ocular adnexa and skin in the study eye, including ocular surface infections
History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after ITV injection or intraocular procedures
Uncontrolled intraocular pressure greater than (\>) 25 millimeters of mercury (mmHg) in the study eye (uncontrolled means that it occurs even with intraocular pressure-lowering therapy)
Use of therapies that are known to be toxic to any ocular tissues within the 6 months prior to enrollment
Prior Ocular Therapies
Treatment with any ITV injection within the 27 days prior to Day 1
Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye at any time during the past 3 months
General
Receipt of any systemic (non-ocular) investigational drug within 3 months prior to Day 1
Current systemic coagulation or bleeding disorders and history of recurrent hemorrhages
Intolerance or known reaction to prior biological therapies
History of other diseases or physical or laboratory examination findings that per the retina specialist represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk.
