Visual impairment due to diabetic macula edema MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Sponsors
NOVARTIS PHARMA SERVICES AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female patients, = 18 years of age. •Written informed consent must be obtained before any assessment is performed. •Type 1 or Type 2 diabetes mellitus according to ADA (2014) and/or WHO (2006) classifications (see Appendix 1, Table 13-2) with glycosylated hemoglobin (HbA1c) = 10% (= 86 mmol/mol) at screening. Patients should be on dietand/or exercise and/or pharmacological treatment for diabetes, which must have been stable for at least 3 months. •Visual impairment due to DME • Patients with a baseline BCVA of 78 to 24 (20/32–20/320) ETDRS letters 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Systemic medical history and conditions •Stroke less than 3 months prior to screening. •Presence of uncontrolled systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening or baseline. •Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening Prior or current systemic medication: •Use of any systemic anti-VEGF drugs (e.g., bevacizumab [Avastin®], ziv-aflibercept [Zaltrap®]) ithin 6 months prior to screening •Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening. •Use of any anti-coagulants agents within 3 months prior to screening Prior or current ocular treatment or conditions: For study eye: •Panretinal laser photocoagulation within 6 months prior to randomization. •Focal/grid laser photocoagulation within 3 months prior to randomization. •Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening. •Application of intravitreal corticosteroids (incl. corticosteroid releasing implant, e.g. Ozurdex®) in vitreous within 6 months prior to screening. Prior application of fluocinolone acetonide releasing implant (Iluvien®) in vitreous within 36 months prior to screening. For fellow eye •Retinal or choroidal neovascularization or macula edema of any cause involving the fovea requiring anti-VEGF treatment at the time of screening or baseline or the anticipation of development of the above mentioned medical conditions requiring anti-VEGF treatment within 6 months past screening or baseline. •History of treatment with any anti-angiogenic drugs (including any anti-VEGF agents, e.g., bevacizumab [Avastin®]) 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab (treatment group 1) versus monthly 2mg aflibercept (treatment group 3) as measured by the area under the curve (AUC) from baseline to study week 24;Secondary Objective: To compare systemic VEGF-A levels in patients switching from monthly 2 mg aflibercept injections for first three months to monthly 0.5 mg ranibizumab (treatment group 2) for the next three months compared to patients treated with monthly 0.5 mg ranibizumab (treatment group 1) for six months at specific time points from week 12 to week 24. To compare systemic VEGF-A levels in patients switching from monthly 2 mg aflibercept injections for first three months to monthly 0.5 mg ranibizumab (treatment group 2) for the next three months compared to patients treated with monthly 2 mg aflibercept (treatment group 3) for six months at specific time points from week 12 to week 24. To evaluate ocular and systemic safety in all the three treatment groups;Primary end point(s): The primary variable is the area under the curve (AUC) of VEGF-A levels in plasma following monthly injections of ranibizumab or aflibercept monotherapy measured between baseline and study week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are the Comparison of systemic VEGF-A levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab or aflibercept from baseline. The comparison will be performed at specific time points between week 12 and week 24.;Timepoint(s) of evaluation of this end point: Week 12 and week 24 | — |
Countries
Canada, France, Germany, Italy
Contacts
Public ContactDrug Regulatory Affairs
NOVARTIS FARMA S.P.A.
Outcome results
None listed