A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema (LUDIC)
Primary Purpose
Visual Impairment, Macular Edema
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Visual Impairment focused on measuring visual impairment, macular edema, ranibizumab, visual impairment due to macular edema
Eligibility Criteria
Inclusion Criteria:
- Male or female patients >18 years of age who have signed an informed consent
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
- Patients with visual impairment due to focal or diffuse DME in at least one eye
- Central Retinal thickness on OCT ≥ 250 microns in the central subfield
- BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160)
- Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
- Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
Exclusion Criteria:
Ocular concomitant conditions/ diseases
- Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
- Active intraocular inflammation (grade trace or above) in either eye
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- History of uveitis in either eye Systemic conditions or treatments
- Active systemic infection
- History of stroke < 3 months
- Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl
- Untreated diabetes mellitus
- Blood pressure systolic > 160 mmHg and diastolic > 100 mmHg
- Untreated hypertension
- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Others
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
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
- 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 Type
Experimental
Arm Label
Ranibizumab
Arm Description
Outcomes
Primary Outcome Measures
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
Secondary Outcome Measures
mean average change in BCVA from baseline
if the letters gain after 2 injections is predictive from the letters gain at 6 months
mean number of injections needed to obtain a 10 letters gain
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)
Full Information
NCT ID
NCT01315275
First Posted
March 11, 2011
Last Updated
February 20, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01315275
Brief Title
A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema
Acronym
LUDIC
Official Title
An Open-label, Multicenter, Phase IV Study of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema in Current Medical Practice
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Macular Edema
Keywords
visual impairment, macular edema, ranibizumab, visual impairment due to macular 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
394 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Primary Outcome Measure Information:
Title
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
mean average change in BCVA from baseline
Time Frame
6 months
Title
if the letters gain after 2 injections is predictive from the letters gain at 6 months
Time Frame
6 months
Title
mean number of injections needed to obtain a 10 letters gain
Time Frame
6 months
Title
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments
Time Frame
6 months
Title
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients >18 years of age who have signed an informed consent
Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
Patients with visual impairment due to focal or diffuse DME in at least one eye
Central Retinal thickness on OCT ≥ 250 microns in the central subfield
BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160)
Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
Exclusion Criteria:
Ocular concomitant conditions/ diseases
Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
Active intraocular inflammation (grade trace or above) in either eye
Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
History of uveitis in either eye Systemic conditions or treatments
Active systemic infection
History of stroke < 3 months
Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl
Untreated diabetes mellitus
Blood pressure systolic > 160 mmHg and diastolic > 100 mmHg
Untreated hypertension
Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Others
Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
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
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Novartis Investigative Site
City
Angers
ZIP/Postal Code
49044
Country
France
Facility Name
Novartis Investigative Site
City
Besançon cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Novartis Investigative Site
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33100
Country
France
Facility Name
Novartis Investigative Site
City
Caen
ZIP/Postal Code
14050
Country
France
Facility Name
Novartis Investigative Site
City
Cesson Sevigne
ZIP/Postal Code
35510
Country
France
Facility Name
Novartis Investigative Site
City
Clermont-ferrand
ZIP/Postal Code
63014
Country
France
Facility Name
Novartis Investigative Site
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69275
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Novartis Investigative Site
City
Mantes la joile
ZIP/Postal Code
78201
Country
France
Facility Name
Novartis Investigative Site
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Novartis Investigative Site
City
Melun
ZIP/Postal Code
77000
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Novartis Investigative Site
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Novartis Investigative Site
City
Osny
ZIP/Postal Code
95520
Country
France
Facility Name
Novartis Investigative Site
City
Paris Cedex 19
ZIP/Postal Code
75940
Country
France
Facility Name
Novartis Investigative Site
City
Paris, Cedex 12
ZIP/Postal Code
F-75571
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novartis Investigative Site
City
Puilboreau
ZIP/Postal Code
17138
Country
France
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
Novartis Investigative Site
City
Saint Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
Novartis Investigative Site
City
Saint Etienne
ZIP/Postal Code
42000
Country
France
Facility Name
Novartis Investigative Site
City
Saitnt Herblain
ZIP/Postal Code
44819
Country
France
Facility Name
Novartis Investigative Site
City
St Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Novartis Investigative Site
City
St-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31077
Country
France
Facility Name
Novartis Investigative Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Novartis Investigative Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Novartis Investigative Site
City
Vannes
ZIP/Postal Code
56000
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema
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