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

Nagoya City University2 sites in 1 country78 target enrollmentJanuary 2014

ConditionsNeovascular Age-related Macular Degeneration

InterventionsIntraviteal Ranibizumab 0.5mg

DrugsIntraviteal Ranibizumab 0.5mg

Overview

Phase: Phase 4
Intervention: Intraviteal Ranibizumab 0.5mg
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Nagoya City University
Enrollment: 78
Locations: 2
Primary Endpoint: Visual acuity
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

March 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nagoya City University

Responsible Party

Principal Investigator

Yuichiro Ogura

Professor

Nagoya City University

Eligibility 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