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

December 26, 2014 updated by: Mineo Kondo, Mie University

Evaluation of the Efficacy and Continuance Rate of Treatment in Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tsu, Japan, 5148507
        • Recruiting
        • Mie University Graduate School Of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ranibizumab
Drug: ranibizumab
0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A change from baselines best corrected visual acuity at 24 months
Time Frame: 24 months
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mie University

Investigators

  • Study Chair: Mineo Kondo, Mie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMIN000014056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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