Visual ImpairmentPhase 4LUDICNCT01315275
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
A Phase 4 study testing Ranibizumab in people with Visual Impairment and Macular Edema, run by Novartis Pharmaceuticals at 43 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Impairment, Macular Edema
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 43 sitesFrance
- Study dates
- Feb 2011to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
France43 sites
Novartis Investigative Site
Amiens, 80054
Novartis Investigative Site
Angers, 49044
Novartis Investigative Site
Besançon, 25030
Novartis Investigative Site
Bobigny, 93009
Novartis Investigative Site
Bordeaux, 33000
Novartis Investigative Site
Bordeaux, 33100
Novartis Investigative Site
Caen, 14050
Novartis Investigative Site
Cesson-Sévigné, 35510
Novartis Investigative Site
Clermont-Ferrand, 63014
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Grenoble, 38000
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Lyon, 69007
Novartis Investigative Site
Lyon, 69275
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Lyon, 69437
Novartis Investigative Site
Mantes La Joile, 78201
Novartis Investigative Site
Marseille, 13008
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Melun, 77000
Novartis Investigative Site
Montpellier, 34000
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nice, 06000
Novartis Investigative Site
Nîmes, 30029
Novartis Investigative Site
Osny, 95520
Novartis Investigative Site
Paris, France, F-75571
Novartis Investigative Site
Paris, 75006
Novartis Investigative Site
Paris, 75007
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Paris, 75940
Novartis Investigative Site
Puilboreau, 17138
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rouen, 76100
Novartis Investigative Site
Saint-Brieuc, 22015
Novartis Investigative Site
Saint-Etienne, 42000
Novartis Investigative Site
Saint-Priest-en-Jarez, 42270
Novartis Investigative Site
Saitnt Herblain, 44819
Novartis Investigative Site
St.-Jean, 31240
Novartis Investigative Site
Strasbourg, 67000
Novartis Investigative Site
Toulouse, 31077
Novartis Investigative Site
Tours, 37044
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Novartis Investigative Site
Vannes, 56000
About this study
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
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.
- Conditions
- Visual Impairment, Macular Edema
- Being tested
- Ranibizumab
- Keywords
- visual impairment, macular edema, ranibizumab, visual impairment due to macular edema
- Medical subject headings
- Vision Disorders, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
Measured: 6 months
Secondary outcomes (5)
mean average change in BCVA from baseline
Measured: 6 months
if the letters gain after 2 injections is predictive from the letters gain at 6 months
Measured: 6 months
mean number of injections needed to obtain a 10 letters gain
Measured: 6 months
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments
Measured: 6 months
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315275
- Sponsor's protocol ID
- CRFB002DFR08
- Other IDs
- 2010-023315-34
- Acronym
- LUDIC
- Status last verified
- Feb 2017
- First submitted
- 11 Mar 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01315275
- Acronym / sponsor ID
- LUDIC / CRFB002DFR08
- Conditions
- Visual Impairment, Macular Edema
- Keywords
- visual impairment, macular edema, ranibizumab, visual impairment due to macular edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumab | Drug | Ranibizumab |
Primary outcome
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
Time frame: 6 months
5 secondary outcomes
mean average change in BCVA from baseline
Time frame: 6 months
if the letters gain after 2 injections is predictive from the letters gain at 6 months
Time frame: 6 months
mean number of injections needed to obtain a 10 letters gain
Time frame: 6 months
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments
Time frame: 6 months
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab in people with Visual Impairment and Macular Edema, run by Novartis Pharmaceuticals at 43 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.