A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary … (NCT02698566) | Clinical Trial Compass
CompletedPhase 3
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)
United States35 participantsStarted 2016-03-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with…
What they're measuring
1
Percentage of Successful Task Completions
Timeframe: Day 1
2
Percentage of PFS Usage Errors on Safety Critical Tasks