Diabetic Macular Edema (DME) MedDRA version: 9.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Sponsors
Novartis Pharma Services AG
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 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. 3.Patients with visual impairment due to focal or diffuse DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. The study eye must fulfill the following criteria at Visit 1 (if both eyes are eligible, the study eye will be selected by the investigator): •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 4.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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 on study treatment 2.Active intraocular inflammation (grade trace or above) in either eye 3.Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) 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 study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia) 7.Uncontrolled glaucoma in the study eye (according to investigator’s judgement) 8.Neovascularization of the iris in study eye 9.Evidence of vitreomacular traction in study eye 10.Active proliferative diabetic retinopathy in the study eye Ocular treatments : 10.Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study 11.Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry 12.Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in study eye within 3 months prior to randomization 13.Any intraocular surgery in the study eye within 3 months prior to randomization 14.History of vitrectomy in study eye 15.Phakic study eye with a history of intravitreal corticosteroid treatment 16.Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids Systemic conditions or treatments 17.History of stroke 18.Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl 19.Untreated diabetes mellitus 20.Blood pressure systolic > 160 mmHg and diastolic > 100 mmHg 21.Untreated hypertension or change in antihypertensive treatment within 3 months preceding Baseline 22.Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol 23.Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Compliance/ Administrative 24.Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to ra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate superiority of ranibizumab 0.5 mg as adjunctive or mono-therapy to laser treatment in the mean change from baseline in BCVA over a 12-month treatment period. ; Secondary Objective: Secondary objectives are •to evaluate whether ranibizumab (0.5 mg) as adjunctive or mono-therapy is superior to laser treatment -in the number of patients with visual acuity above 73 letters and -in the number of patients with improvement in BCVA. •to evaluate the time course of BCVA changes on ranibizumab (0.5 mg) adjunctive and mono-therapy relative to laser treatment •to evaluate the effects of ranibizumab (0.5 mg) adjunctive and mono-therapy on central retinal thickness and other anatomical changes relative to laser treatment •to evaluate the effects of ranibizumab (0.5 mg) adjunctive and mono-therapy on patient-reported outcomes (PROs) relative to laser treatment •to evaluate the safety of intravitreal injections of ranibizumab (0.5 mg) as adjunctive and mono-therapy in patients with DME overall and relative to laser treatment. ;Primary end point(s): The primary objective is to demonstrate superiority of ranibizumab 0,5 mg as adjunctive and/or mono-therapy to laser treatment in the mean change from baseline in BCVA over a 12-month treatment period. The primary variable will be the difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 12 and the baseline level of BCVA. | — |
Countries
Belgium, France, Germany, Greece, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed