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

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ClinicalTrials.gov Identifier: NCT02321839
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Yuichiro Ogura, Nagoya City University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: Intraviteal Ranibizumab 0.5mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.
Study Start Date : January 2014
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Intraviteal Ranibizumab 0.5mg
Intraviteal Ranibizumab 0.5mg
Drug: Intraviteal Ranibizumab 0.5mg
Intraviteal Ranibizumab 0.5mg




Primary Outcome Measures :
  1. Visual acuity [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. central foveal thickness [ Time Frame: One and two years ]

Other Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321839


Locations
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Japan
Sugita Eye Hospital
Nagoya, Aichi, Japan, 460-0008
Nagoya City Univsersity
Nagoya, Aichi, Japan, 467-8602
Sponsors and Collaborators
Nagoya City University
Novartis
Investigators
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Study Chair: Yuichiro Ogura Nagoya City Univsersity

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Responsible Party: Yuichiro Ogura, Professor, Nagoya City University
ClinicalTrials.gov Identifier: NCT02321839    
Other Study ID Numbers: TAENCU001
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yuichiro Ogura, Nagoya City University:
neovascular age-related macular degeneration
Ranibizumab
Treat and extend
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents