Phase 3
Completed N=38
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)
Source: ClinicalTrials.gov NCT02698566 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Successful Task Completions — 100; 100; 100; 100 percentage of tasks
◆ Published Evidence
Emerging
4citations · ~1 / year
Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals.
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.
Linked Publications
-
Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Successful Task Completions |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Percentage of PFS Usage Errors on Safety Critical Tasks |
— | — |
| PRIMARY Percentage of PFS Usage Errors on Essential Tasks |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02698566) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.