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)
- Eye Disorder
- Macular Edema
- Age-Related Macular Degeneration
Completed
- Charlotte
- Chattanooga
- Germantown
- Paducah
NCT02698566 GX30020
Trial 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.
An Open-Label, Single-Arm Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration or Macular Edema Secondary to Retinal Vein Occlusion to Evaluate the Usability of Lucentis® 0.5 mg Prefilled Syringe
Eligibility Criteria
Ocular
- Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist
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
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