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

Phase 4

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Intraviteal Ranibizumab 0.5mg

• Registration Number: NCT02321839
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Status Verified: 2016-10
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-08-17
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraviteal Ranibizumab 0.5mg	Intraviteal Ranibizumab 0.5mg	Intraviteal Ranibizumab 0.5mg

Primary Outcome Measures

Name	Time	Method
Visual acuity	One Year

Secondary Outcome Measures

Name	Time	Method
central foveal thickness	One and two years

Trial Locations

Locations (2)

Nagoya City Univsersity; 🇯🇵 Nagoya, Aichi, Japan

Sugita Eye Hospital; 🇯🇵 Nagoya, Aichi, Japan