A Study in Participants With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Lucentis® Prefilled Syringe



Status:Recruiting
Conditions:Cardiology, Ocular, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2016
End Date:April 2016
Contact:Reference Study ID Number: GX30020 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

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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® PREFILLED SYRINGE 0.5 mg

This is a multicenter study designed to evaluate usability of Lucentis prefilled syringe
(PFS) in participants with neovascular age related macular degeneration or macular edema
secondary to retinal vein occlusion.

The purpose of this study is to assess the ability of health care providers (HCPs) to follow
the instructions for use (IFU) to prepare and administer a Lucentis PFS ITV injection dose
to patients.

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

- Participants 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 millimeter 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
We found this trial at
4
sites
Charlotte, North Carolina 28207
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