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

Mie University

Status: Unknown

Conditions: Exudative Age-related Macular Degeneration

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02328209

UMIN000014056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ranibizumab

Experimental group

Description:

ranibizumab

Treatment:

Drug: ranibizumab