Clinical trial NCT02698566: 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)
Official title: 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® 0.5 mg Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.

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

Primary outcomes:
measure: Percentage of Successful Task Completions
timeFrame: Day 1
measure: Percentage of PFS Usage Errors on Safety Critical Tasks
timeFrame: Day 1
measure: Percentage of PFS Usage Errors on Essential Tasks
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Chattanooga
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Germantown
country: United States
facility: Charles Retina Institution
state: Tennessee
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.