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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328209
Recruitment Status : Unknown
Verified December 2014 by Mineo Kondo, Mie University.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Mineo Kondo, 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.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: ranibizumab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: ranibizumab
ranibizumab
Drug: ranibizumab
0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
Other Name: Lucentis




Primary Outcome Measures :
  1. A change from baselines best corrected visual acuity at 24 months [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. A drop-out rate of the 3 and 12 months [ Time Frame: 3 and 12 months ]
  2. A treatment continuance rate until 24 months [ Time Frame: 24 months ]
  3. A change of best corrected visual acuity at 12 months [ Time Frame: 12 months ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328209


Locations
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Japan
Mie University Graduate School of Medicine Recruiting
Tsu, Japan, 5148507
Contact: Mineo Kondo    +81592321111 ext 6461    ganka@clin.medic.mie-u.ac.jp   
Sponsors and Collaborators
Mie University
Investigators
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Study Chair: Mineo Kondo Mie University
Publications of Results:
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Responsible Party: Mineo Kondo, Mie University Graduate School of Medicine, Mie University
ClinicalTrials.gov Identifier: NCT02328209    
Other Study ID Numbers: UMIN000014056
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents