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)
NCT ID: NCT02698566
Last Updated: 2017-09-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2016-03-21
2016-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ranibizumab PFS
Healthcare professionals (HCPs) will administer ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
Ranibizumab
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Interventions
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Ranibizumab
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Countries
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References
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Antoszyk AN, Baker C, Calzada J, Cummings H, So J, Quezada-Ruiz C, Haskova Z. Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):411-419. doi: 10.5731/pdajpst.2017.008342. Epub 2018 May 31.
Other Identifiers
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GX30020
Identifier Type: -
Identifier Source: org_study_id