Back to resultsStudy of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema (DIVERSE)
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ranibizumab 0.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic macular edema, Visual impairment
Eligibility Criteria
Inclusion Criteria:
- Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
- Patients with visual impairment due to DME in at least one eye
- BCVA ≥ 24 and ≤ 78 letters in the study eye
Exclusion Criteria:
- Active intraocular inflammation
- Any active infection in either eye at the
- Structural damage within 0.5 disc diameter of the center of the macula in the study eye
- Uncontrolled glaucoma in either eye at screening
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Discretion of the investigator (DI)
Pro re nata (PRN)
Arm Description
ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.
ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred
Outcomes
Primary Outcome Measures
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity
Secondary Outcome Measures
Number of Visits
Mean number of visits during the study
Number of Injections
mean number of injections in the study eye during the study
Number of Treatment Free Intervals
A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.
Mean Change in Central Subfield Retinal Thickness (CSRT)
Evaluated by central reading center assessing OCT images
Mean Change of Foveal Center Point Thickness
Evaluated by central reading center assessing OCT images
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
Evaluated by central reading center scoring fundus photography
Full Information
NCT ID
NCT02366468
First Posted
January 12, 2015
Last Updated
January 1, 2019
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02366468
Brief Title
Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
Acronym
DIVERSE
Official Title
A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2015 (Actual)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetic macular edema, Visual impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Discretion of the investigator (DI)
Arm Type
Experimental
Arm Description
ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.
Arm Title
Pro re nata (PRN)
Arm Type
Active Comparator
Arm Description
ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred
Intervention Type
Drug
Intervention Name(s)
ranibizumab 0.5 mg
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal injection
Primary Outcome Measure Information:
Title
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
Description
BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity
Time Frame
Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary Outcome Measure Information:
Title
Number of Visits
Description
Mean number of visits during the study
Time Frame
Baseline to Month 12
Title
Number of Injections
Description
mean number of injections in the study eye during the study
Time Frame
Baseline to Month 12
Title
Number of Treatment Free Intervals
Description
A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.
Time Frame
Baseline to Month 12
Title
Mean Change in Central Subfield Retinal Thickness (CSRT)
Description
Evaluated by central reading center assessing OCT images
Time Frame
Baseline to Month 12
Title
Mean Change of Foveal Center Point Thickness
Description
Evaluated by central reading center assessing OCT images
Time Frame
Baseline to Month 12
Title
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
Description
Evaluated by central reading center scoring fundus photography
Time Frame
Baseline to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
Patients with visual impairment due to DME in at least one eye
BCVA ≥ 24 and ≤ 78 letters in the study eye
Exclusion Criteria:
Active intraocular inflammation
Any active infection in either eye at the
Structural damage within 0.5 disc diameter of the center of the macula in the study eye
Uncontrolled glaucoma in either eye at screening
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
Novartis Investigative Site
City
Bayreuth
ZIP/Postal Code
95444
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Novartis Investigative Site
City
Düsseldorf
ZIP/Postal Code
40212
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg I. Br
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle
ZIP/Postal Code
06114
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Hösbach
ZIP/Postal Code
63768
Country
Germany
Facility Name
Novartis Investigative Site
City
Kempten
ZIP/Postal Code
87435
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Novartis Investigative Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
München
ZIP/Postal Code
80333
Country
Germany
Facility Name
Novartis Investigative Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Novartis Investigative Site
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
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