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)
Condition: Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Ranibizumab
Intervention description: Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients
      with neovascular age related macular degeneration or macular edema secondary to retinal vein
      occlusion.
    

Eligibility criteria:

        Inclusion Criteria:

        Ocular

          -  Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the
             retina specialist

        Exclusion Criteria:

        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.

          -  Uncontrolled hypertension (systolic >160 mmHg and/or diastolic >100 mmHg while
             sitting)

          -  Current systemic infectious disease or a therapy for active infectious disease

          -  Pregnant or lactating