Back to resultsIntravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- diabetes mellitus (1 or2)
- decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity<69 letters using E.T.D.R.S testing)
- macular edema
Exclusion Criteria:
- history of severe cardiac disease
- stroke within 12 months
- intraocular inflammation
Sites / Locations
- Chu de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ranibizumab
Arm Description
Outcomes
Primary Outcome Measures
Number of intravitreal injections of ranibizumab
Secondary Outcome Measures
best-corrected visual acuity
Full Information
NCT ID
NCT01823965
First Posted
March 27, 2013
Last Updated
March 29, 2016
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01823965
Brief Title
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief Summary
In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Primary Outcome Measure Information:
Title
Number of intravitreal injections of ranibizumab
Time Frame
1 years
Secondary Outcome Measure Information:
Title
best-corrected visual acuity
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diabetes mellitus (1 or2)
decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity<69 letters using E.T.D.R.S testing)
macular edema
Exclusion Criteria:
history of severe cardiac disease
stroke within 12 months
intraocular inflammation
Facility Information:
Facility Name
Chu de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
We'll reach out to this number within 24 hrs