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)

Completed · Phase 3

Conditions studied: Macular Edema

In brief

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.

Key facts

Study ID

NCT02698566

Run by

Genentech, Inc.

People needed

35

Starts

2016-03-21

Expected to finish

2016-04-05

Last updated by the study team

2017-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ocular
• Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist

You may not qualify 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.
• 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

Where it is running

• Paducah Retinal Center — Paducah, Kentucky, United States
• Char Eye Ear &Throat Assoc — Charlotte, North Carolina, United States
• Southeastern Retina Associates — Chattanooga, Tennessee, United States
• Charles Retina Institution — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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