Back to resultsCombination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
Primary Purpose
Diabetic Macula Edema
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Photocoagulation
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macula Edema
Eligibility Criteria
Inclusion Criteria:
- stable medication for the management of diabetes within 3 months
- visual impairment due to focal or diffuse diabetic macula edema
- decreased vision due to diabetic macula edema and not other causes
Exclusion Criteria:
- concomitant conditions in the study eye that could prevent the improvement in VA on the study
- active intraocular inflammation or infection in either eye
- uncontrolled glaucoma in either eye
- treatment with antiangiogenic drugs in the study eye within 3 months
- history of stroke and uncontrolled hypertension
Sites / Locations
- Department ou Ophthalmology Shinshu University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab with Photocoagulation
Arm Description
Outcomes
Primary Outcome Measures
best corrected visual acuity
Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131350
Brief Title
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macula Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab with Photocoagulation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Photocoagulation
Intervention Description
Photocoagulation include focal/grid laser and/or panretinal photocoagulation
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Primary Outcome Measure Information:
Title
best corrected visual acuity
Description
Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.
Time Frame
every month, up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable medication for the management of diabetes within 3 months
visual impairment due to focal or diffuse diabetic macula edema
decreased vision due to diabetic macula edema and not other causes
Exclusion Criteria:
concomitant conditions in the study eye that could prevent the improvement in VA on the study
active intraocular inflammation or infection in either eye
uncontrolled glaucoma in either eye
treatment with antiangiogenic drugs in the study eye within 3 months
history of stroke and uncontrolled hypertension
Facility Information:
Facility Name
Department ou Ophthalmology Shinshu University School of Medicine
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
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