Clincosm LogoSign in Get a demo

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

Sponsor
Mie University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02328209
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
30
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy and Continuance Rate of Treatment in Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration
Study Start Date :
Jun 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ranibizumab

ranibizumab

Drug: ranibizumab
0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. A change from baselines best corrected visual acuity at 24 months [24 months]

    Secondary Outcome Measures

    1. A drop-out rate of the 3 and 12 months [3 and 12 months]

    2. A treatment continuance rate until 24 months [24 months]

    3. A change of best corrected visual acuity at 12 months [12 months]

    4. A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months [12 and 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mie University Graduate School of Medicine Tsu Japan 5148507

    Sponsors and Collaborators

    • Mie University

    Investigators

    • Study Chair: Mineo Kondo, Mie University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mineo Kondo, Mie University Graduate School of Medicine, Mie University
    ClinicalTrials.gov Identifier:
    NCT02328209
    Other Study ID Numbers:
    • UMIN000014056
    First Posted:
    Dec 31, 2014
    Last Update Posted:
    Dec 31, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration
    Ranibizumab

    Study Results

    No Results Posted as of Dec 31, 2014