diabetic macular edema MedDRA version: 12.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Sponsors
Novartis Pharma GmbH
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 [ADA Guidelines, 2008][WHO Guidelines, 2006]) 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. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate to receive study treatment. The study eye must fulfill the following criteria at Visit 1: • 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: 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 or any suspicion of an 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/12 month follow up period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularisation of any cause other than DME/PDR (e.g., AMD, ocular histoplasmosis, or pathologic myopia) 7. Uncontrolled glaucoma in either eye (e.g. IOP > 24 mmHg on medications, or according to investigator’s judgment) 8. Neovascularisation of the iris in either eye 9. Evidence of vitreomacular traction in either eye 10. Vitreous bleeding of any cause 11. Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) = 24 letters (approximate Snellen equivalent of 20/320) at Visit 1 12. Panretinal laser photocoagulation in the study eye within 6 months prior to the study 13. Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry 14. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, Ranibizumab, etc.) in study eye within 3 months prior to randomization 15. Any intraocular surgery in the study eye within 3 months prior to randomization 16. History of vitrectomy in study eye 17. History of intravitreal corticosteroid treatment in phakic study eye 18. Intravitreal corticosteroids in post-cataract surgical study eyes (aphakic or pseudophakic without damaged posterior capsule) within 3 months prior to randomization 19. Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids 20. History of stroke and history of transient ischemic attack (TIA) 21. Renal failure requiring dialysis or renal transplant OR renal insufficiency with GFR 160 mmHg or diastolic > 100 mmHg 24. Untreated hypertension or change in antihypertensive treatment within 3 months preceding Baseline 25. 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 26. Known hypersensitivity to Ranibizumab or any component of the Ranibizumab formulation or fluorescein 28. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrences or metastases 27. Any type of advanced, severe or unstable disease or its treatment, that could interfere with primary and/or secondary outcome evaluations including any medical condition that could be expected to progr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate superiority of an adjunctive treatment of laser photocoagulation to Ranibizumab 0.5 mg as intravitreal injection in the mean change in BCVA from baseline to month 12 compared to laser monotherapy.;Secondary Objective: Secondary objectives are • to evaluate whether laser adjunctive to Ranibizumab is superior to laser monotherapy after 12 month in terms of o number of patients with visual acuity > 73 ETDRS letters o number of patients with = 15 ETDRS letters gain o number of patients with improvement in BCVA o number of patients with loss of = 15 ETDRS letters • to evaluate the time course of BCVA within the two treatment arms. • to evaluate the effects of the treatment arms on central retina thickness and other anatomical changes as well as on patient-reported outcomes (PROs) • to evaluate the safety for each of the treatment arms • to evaluate the total number of laser treatments and Ranibizumab 0.5 mg intravitreal injections required over the 12/24 month study period • to evaluate the outcome in BCVA in the subgroup of patients with PDR ;Primary end point(s): The primary objective of this study is to demonstrate superiority of adjunctive treatment (laser treatment as adjunctive to Ranibizumab 0.5 mg as intravitreal injection) in the mean change in BCVA from baseline to month 12 compared to laser monotherapy. | — |
Countries
Germany
Outcome results
None listed