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

NCT ID: NCT02328209

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Exudative Age-related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ranibizumab

ranibizumab

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks

Interventions

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ranibizumab

0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mie University

OTHER

Sponsor Role lead

Responsible Party

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Mineo Kondo

Mie University Graduate School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mineo Kondo

Role: STUDY_CHAIR

Mie University

Locations

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Mie University Graduate School of Medicine

Tsu, , Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Mineo Kondo

Role: primary

References

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Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

Reference Type RESULT
PMID: 17021319 (View on PubMed)

Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

Reference Type RESULT
PMID: 17021318 (View on PubMed)

Other Identifiers

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UMIN000014056

Identifier Type: -

Identifier Source: org_study_id