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)

• Status: Completed
• Trial end date: 2016-04-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Ranibizumab

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