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)

  • Eye Disorder
  • Age-Related Macular Degeneration
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT02698566 GX30020

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 3 Phase
      NCT02698566,GX30020 Trial Identifier
      Ranibizumab Treatments
      Macular Edema Condition
      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

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      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

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