search
Back to results

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

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Mie University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mie University Graduate School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

ranibizumab

Outcomes

Primary Outcome Measures

A change from baselines best corrected visual acuity at 24 months

Secondary Outcome Measures

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

Full Information

First Posted
December 19, 2014
Last Updated
December 26, 2014
Sponsor
Mie University
search

1. Study Identification

Unique Protocol Identification Number
NCT02328209
Brief Title
Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mie University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab
Arm Type
Experimental
Arm Description
ranibizumab
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
Primary Outcome Measure Information:
Title
A change from baselines best corrected visual acuity at 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
A drop-out rate of the 3 and 12 months
Time Frame
3 and 12 months
Title
A treatment continuance rate until 24 months
Time Frame
24 months
Title
A change of best corrected visual acuity at 12 months
Time Frame
12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ability to provide written informed consent for this study age>=50years old intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV) best corrected visual acuity>=0.05 - Exclusion Criteria: past intravitreal anti-vascular endothelial growth factor therapy in the study eye past intravitreal or subtenon injection of steroid therapy in the study eye past vitrectomy therapy in the study eye infection or suspicion of infection in eyes or periocular region severe intraocular inflammation in eyes past allergic reaction for ranibizumab past allergic reaction for fluorescein, indocyanine green or iodine pregnancy (positive pregnancy test) or lactating women other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mineo Kondo
Organizational Affiliation
Mie University
Official's Role
Study Chair
Facility Information:
Facility Name
Mie University Graduate School of Medicine
City
Tsu
ZIP/Postal Code
5148507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mineo Kondo
Phone
+81592321111
Ext
6461
Email
ganka@clin.medic.mie-u.ac.jp

12. IPD Sharing Statement

Citations:
PubMed Identifier
17021319
Citation
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.
Results Reference
result
PubMed Identifier
17021318
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs