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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321839
• Other study ID #: TAENCU001
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: October 2016
• Source: Nagoya City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Intraviteal Ranibizumab 0.5mg
Intraviteal Ranibizumab 0.5mg

Locations

Country	Name	City	State
Japan	Nagoya City Univsersity	Nagoya	Aichi
Japan	Sugita Eye Hospital	Nagoya	Aichi

Sponsors (2)

Lead Sponsor	Collaborator
Nagoya City University	Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital Anxiety and Depression Scale	The mean change from baseline in Hospital Anxiety and Depression Scale at week 52 and 104.	one and two years
Primary	Visual acuity		One Year
Secondary	central foveal thickness		One and two years