Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration

Not Applicable

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Drug: ranibizumab

• Registration Number: NCT02328209
• Lead Sponsor: Mie University

Brief Summary

Recently studies have shown that intravitreal injection of ranibizumab is effective for age related macular degeneration. However there are problems about injection regimen of maintenance phase. We plan to perform new simplified treat and extend regimen using ranibizumab.

Detailed Description

The purpose of the present study is to evaluate the simplified treat and extend regimen using ranibizumab in eyes with wet age related macular degeneration about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-26
• Last Update Submitted: 2014-12-26
• Study First Posted: 2014-12-31
• Last Update Posted: 2014-12-31
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. ability to provide written informed consent for this study
2. age>=50years old
3. intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV)
4. best corrected visual acuity>=0.05 -

Exclusion Criteria

1. past intravitreal anti-vascular endothelial growth factor therapy in the study eye
2. past intravitreal or subtenon injection of steroid therapy in the study eye
3. past vitrectomy therapy in the study eye
4. infection or suspicion of infection in eyes or periocular region
5. severe intraocular inflammation in eyes
6. past allergic reaction for ranibizumab
7. past allergic reaction for fluorescein, indocyanine green or iodine
8. pregnancy (positive pregnancy test) or lactating women
9. other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ranibizumab	ranibizumab	ranibizumab

Primary Outcome Measures

Name	Time	Method
A change from baselines best corrected visual acuity at 24 months	24 months

Secondary Outcome Measures

Name	Time	Method
A change of best corrected visual acuity at 12 months	12 months
A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months	12 and 24 months
A drop-out rate of the 3 and 12 months	3 and 12 months
A treatment continuance rate until 24 months	24 months

Trial Locations

Locations (1)

Mie University Graduate School of Medicine; 🇯🇵 Tsu, Japan