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OpenTrials
Completed

NCT Number: NCT02321839

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nagoya City Univsersity, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraviteal Ranibizumab 0.5mg

Drug

Intraviteal Ranibizumab 0.5mg

Primary outcomes

  1. Visual acuity

    Time frame: One Year

Secondary outcomes

  1. central foveal thickness

    Time frame: One and two years

Other outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: one and two years

    The mean change from baseline in Hospital Anxiety and Depression Scale at week 52 and 104.

Sponsors and collaborators

Lead sponsor

Nagoya City University

Other

Collaborators

  • Novartis

Registry information

Official study title

Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2014
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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