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)

Genentech

Status and phase: Completed; Phase 3

Conditions: Macular Edema

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02698566

GX30020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Ranibizumab PFS

Experimental group

Description:

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.

Treatment:

Drug: Ranibizumab