Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular AMD.

Overview

To evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.

Full Title of Study: “Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2019

Detailed Description

Treat and Extend Regimen (TER) may contribute to the improvement to a patients' mentality, since the treatment intervals are extended if there were no signs of recurrence. Therefore, we have planned to examine the psychological impact of TER using Hospital Anxiety and Depression Scale (HADS), in addition to the improvement of visual acuity and central retinal thickness.

Interventions

  • Drug: Intraviteal Ranibizumab 0.5mg
    • Intraviteal Ranibizumab 0.5mg

Arms, Groups and Cohorts

  • Experimental: Intraviteal Ranibizumab 0.5mg
    • Intraviteal Ranibizumab 0.5mg

Clinical Trial Outcome Measures

Primary Measures

  • Visual acuity
    • Time Frame: One Year

Secondary Measures

  • central foveal thickness
    • Time Frame: One and two years

Participating in This Clinical Trial

Inclusion Criteria

  • Signed informed consent form – Male or female of aged 50 years or older – Typical AMD and PCV patients – BCVA of 24 letters or over Exclusion Criteria:

  • Total lesion area of >12 DA or >30.5 mm2 – The existence of subretinal hemorrhage area constituting ≥50% of total lesion area – The existence of scar or fibrosis area constituting ≥50% of total lesion area – The existence of RPE tear – Prior treatment for wet AMD – History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD – The pregnant or lactating woman

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nagoya City University
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuichiro Ogura, Professor – Nagoya City University
  • Overall Official(s)
    • Yuichiro Ogura, Study Chair, Nagoya City Univsersity

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