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)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01315275
First received: March 11, 2011
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Visual Impairment Macular Edema |
Drug: Ranibizumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Ranibizumab
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- mean average change in BCVA from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- if the letters gain after 2 injections is predictive from the letters gain at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- mean number of injections needed to obtain a 10 letters gain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- efficacy of ranibizumab IVT on Central Retinal Thickness (OCT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 394 |
| Study Start Date: | February 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ranibizumab | Drug: Ranibizumab |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315275
Locations
| France | |
| Novartis Investigative Site | |
| Amiens, France, 80054 | |
| Novartis Investigative Site | |
| Angers, France, 49044 | |
| Novartis Investigative Site | |
| Besançon cedex, France, 25030 | |
| Novartis Investigative Site | |
| Bobigny, France, 93009 | |
| Novartis Investigative Site | |
| Bordeaux, France, 33000 | |
| Novartis Investigative Site | |
| Bordeaux, France, 33100 | |
| Novartis Investigative Site | |
| Caen, France, 14050 | |
| Novartis Investigative Site | |
| Cesson Sevigne, France, 35510 | |
| Novartis Investigative Site | |
| Clermont-ferrand, France, 63014 | |
| Novartis Investigative Site | |
| Créteil, France, 94000 | |
| Novartis Investigative Site | |
| Grenoble, France, 38000 | |
| Novartis Investigative Site | |
| Lille, France, 59037 | |
| Novartis Investigative Site | |
| Lyon, France, 69275 | |
| Novartis Investigative Site | |
| Lyon, France, 69007 | |
| Novartis Investigative Site | |
| Lyon, France, 69437 | |
| Novartis Investigative Site | |
| Lyon Cedex 04, France, 69317 | |
| Novartis Investigative Site | |
| Mantes la joile, France, 78201 | |
| Novartis Investigative Site | |
| Marseille, France, 13008 | |
| Novartis Investigative Site | |
| Marseille cedex 05, France, 13385 | |
| Novartis Investigative Site | |
| Melun, France, 77000 | |
| Novartis Investigative Site | |
| Montpellier, France, 34000 | |
| Novartis Investigative Site | |
| Montpellier, France, 34295 | |
| Novartis Investigative Site | |
| Nice, France, 06000 | |
| Novartis Investigative Site | |
| Nimes, France, 30029 | |
| Novartis Investigative Site | |
| Osny, France, 95520 | |
| Novartis Investigative Site | |
| Paris, France, 75015 | |
| Novartis Investigative Site | |
| Paris, France, 75007 | |
| Novartis Investigative Site | |
| Paris, France, 75006 | |
| Novartis Investigative Site | |
| Paris Cedex 19, France, 75940 | |
| Novartis Investigative Site | |
| Paris, Cedex 12, France, F-75571 | |
| Novartis Investigative Site | |
| Puilboreau, France, 17138 | |
| Novartis Investigative Site | |
| Reims, France, 51092 | |
| Novartis Investigative Site | |
| Rouen, France, 76100 | |
| Novartis Investigative Site | |
| Saint Brieuc, France, 22015 | |
| Novartis Investigative Site | |
| Saint Etienne, France, 42000 | |
| Novartis Investigative Site | |
| Saitnt Herblain, France, 44819 | |
| Novartis Investigative Site | |
| St Jean, France, 31240 | |
| Novartis Investigative Site | |
| St-Priest-en-Jarez, France, 42270 | |
| Novartis Investigative Site | |
| Strasbourg, France, 67000 | |
| Novartis Investigative Site | |
| Toulouse, France, 31077 | |
| Novartis Investigative Site | |
| Tours, France, 37044 | |
| Novartis Investigative Site | |
| Vandoeuvre les Nancy, France, 54511 | |
| Novartis Investigative Site | |
| Vannes, France, 56000 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01315275 History of Changes |
| Other Study ID Numbers: | CRFB002DFR08, 2010-023315-34 |
| Study First Received: | March 11, 2011 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Novartis:
|
visual impairment macular edema ranibizumab visual impairment due to macular edema |
Additional relevant MeSH terms:
|
Edema Macular Edema Vision, Low Vision Disorders Signs and Symptoms Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013