Diabetic macular edema MedDRA version: 14.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: LUCENTIS*INIET 1FL 0,23ML 10MG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients >18 years of age who have signed an informed consent. 2. Patients with Type 1 or Type 2 DM (according to ADA or WHO guidelines). 3. Patients diagnosed with visual impairment due to focal or diffuse DME in at least one eye for whom no suitable therapeutic alternatives exist (i.e. existing therapies, e.g. laser photocoagulation, have failed or are not indicated). 4. If both eyes are eligible, the one with the worst visual acuity, as assessed at Visit 1, will be selected for treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 630 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Ocular concomitant conditions/ diseases:1.Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity while on treatment;2.Active intraocular inflammation in either eye;3.Any active infection in either eye;4.History of uveitis in either eye;5.Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques;6.Ocular disorders in the study eye that may confound interpretation of results, compromise visual acuity or require medical or surgical intervention during the program period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause;7.Uncontrolled glaucoma in either eye;8.Neovascularization of the iris in either eye;9.Evidence of vitreomacular traction in either eye;10.Active proliferative diabetic retinopathy in the study eye;11.Patients who are monocular or have a BCVA score in the non-study eye = 24 letters at Visit 1. Ocular treatments:12.Panretinal laser photocoagulation in the study eye within 6 months prior to program entry;13.Focal/grid laser photocoagulation in the study eye within 3 months prior to program entry;14.Treatment with anti-angiogenic drugs within 1 month prior to enrollment;15. Any intraocular surgery in the study eye within 3 months prior to enrollment;16.History of vitrectomy in study eye. Systemic conditions or treatments:17.Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl;18.Patient with HbA1c = 12%;19.Hypertension uncontrolled by medication;20.Untreated hypertension or change in antihypertensive treatment within 3 months preceding screening;21.Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation. Compliance/ Administrative:22.Pregnant or nursing (lactating) women;23.Women of childbearing potential UNLESS using effective contraception during treatment;24.Inability to comply with program procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide early access to ranibizumab in patients with macular edema and visual impairment secondary to diabetes mellitus for whom no suitable therapeutic alternatives exist (i.e. existing therapies, e.g. laser photocoagulation, have failed or are not indicated).;Secondary Objective: To generate, in an Italian population resembling that of future clinical practice, additional safety and tolerability data of ranibizumab in patients with visual impairment due to DME, administered according to the label approved by CHMP.;Primary end point(s): No formal statistical tests will be performed.;Timepoint(s) of evaluation of this end point: N.A. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No formal statistical tests will be performed.;Timepoint(s) of evaluation of this end point: N.A. | — |
Countries
Italy
Contacts
Public ContactDrug Regulatory Affairs
NOVARTIS FARMA
Outcome results
None listed