Visual impairment due to diabetic macular edema MedDRA version: 19.0 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient: 1. Male or female patients > 18 years of age giving written Informed Consent and who are willing and capable to comply with all study procedures. 2. Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) = 12.0% (107 mmol/mol) at screening (Visit 1). Inclusion criteria for the study eye at screening: 3. Patients with visual impairment due to DME in at least one eye. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye. 4. BCVA = 24 and = 78 letters in the study eye, using ETDRS-like visual acuity testing charts at a testing distance of 4 resp. 1 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening. 5. Concomitant conditions in the study eye are only permitted if, they do not prevent improvement of visual acuity on study treatment 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 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Patient Compliance/ Administrative: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Ocular medical history: 3. Active intraocular inflammation (grade trace or above) in either eye at enrollment. 4. Any active infection (e.g. conjunctivitis, keratitis, scleritis, endophthalmitis) in either eye at the time of enrollment. 5. History of uveitis (any cause) in either eye at any time. 6. Structural damage within 0.5 disc diameter of the center of the macular 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). 7. Patients with both, a BCVA score of > 73 letters and a central subfield thickness (CSFT) of 24 mmHg on medication or according to investigator’s judgment). 9. Neovascularization of the iris in either eye. 10. Vitreous hemorrhage impairing the adequate diagnosis of DME in the study eye 11. Evidence of clinically relevant vitreofoveal adhesion in the opinion of the investigator, vitreofoveal traction with foveal involvement or epiretinal membrane with foveal involvement in the study eye that is likely to prevent improvement of BCVA loss due to DME. 12. Proliferative vitreoretinopathy in study eye. 13. History of retinal detachment, retinal tear or macular hole in the study eye. 14. Neovascularization covering an area of = 2 disc areas within the macula (defined as area with 6mm diameter centered on the fovea), originating either from neovascularization of the disc or multiple neovascularization’s elsewhere in study eye. 15. 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. Prior and planned Ocular treatments: 16. Any intraocular surgery in the study eye within 4 months prior to randomization. 17. Vitrectomy/vitreoretinal surgery a. In the medical history or planned for study eye b. planned vitrectomy or vitrectomy in last 3 months in fellow eye 18. Planned medical or surgical intervention during the 12-months study period likely to interfere with study schedule or outcomes. 19. Panretinal laser or focal/grid laser photocoagulation in the study eye within 3 months prior to randomization unless sufficient documentation of laser photocoagulation in that period of time is available. 20. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, VEGF-Trap, etc.) - within 3 months prior to randomization for study eye - within 1 month prior randomization for fellow eye. 21. Use of other investigational drugs at the time of enrollment, or within 3 months or 5 half-lives from enrollment, whichever is longer. 22. History of intravitreal corticosteroid treatment in phakic study eye. 23. Intravitreal corticosteroids in post-cataract surgery study eye (aphakic or pseudophakic, without damaged posterior capsule) within 3 months or 6 months for dexamethasone implant (Ozurdex®) or 3 years for fluocinolone implant (Iluvien®)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate: • Mean change of visual acuity by comparing change of BCVA in ETDRS letters between baseline and month 12 • Frequency of visits and injections, treatment free and visit intervals • mean change of central subfield retinal thickness (CSRT) and foveal center point thickness from baseline will be evaluated by central reading center assessing OCT images • change in DRS retinopathy scale evaluated by central reading center scoring fundus photography • Influence of relevant HbA1c-, blood pressure and blood lipid levels changes on primary objective (ANCOVA Analysis) ;Primary end point(s): To demonstrate that the mean average change of BCVA in patients with DME treated with ranibizumab injections at the discretion of the investigator (DI) and in accordance with disease activity criteria is non-inferior to current standard of care (PRN).;Timepoint(s) of evaluation of this end point: month 12;Main Objective: The primary objective is to demonstrate that the mean average change of BCVA in patients with DME treated with ranibizumab injections at the discretion of the investigator (DI) and in accordance with disease activity criteria is non-inferior to current standard of care (PRN). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of: • Mean change of visual acuity by comparing change of BCVA in ETDRS letters between baseline and month 12 • Frequency of visits and injections, treatment free and visit intervals • mean change of central subfield retinal thickness (CSRT) and foveal center point thickness from baseline will be evaluated by central reading center assessing OCT images • change in DRS retinopathy scale evaluated by central reading center scoring fundus photography • Influence of relevant HbA1c-, blood pressure and blood lipid levels changes on primary objective (ANCOVA Analysis) ;Timepoint(s) of evaluation of this end point: month 12 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed