Diabetic Macular Edema (DME) in hypertensive patients MedDRA version: 19.0 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Rasilez 300mg film-coated tablets
Product Name: Rasliez
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ALISKIREN
CAS Number: 173334-57-1
Current Sponsor
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients age 18 to 85 years of age inclusive, with type 1 or type 2 diabetes that is actively managed by a physician with hemoglobin A1C that is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Macular atrophy/scarring/fibrosis, or exudates in the study eye that would preclude improvement in visual acuity. 2. Media opacity in the study eye of sufficient severity to interfere with detection of a 3 line improvement in acuity compared to baseline. 3. Any progressive disease of the retina (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g. glaucoma) other than diabetic retinopathy. 4. Proliferative diabetic retinopathy or severe preproliferative diabetic retinopathy in the study eye that should, in the opinion of the investigator, be treated by photocoagulation within 16 weeks of the screening visit. 5. Intra-ocular pressure > 25 mmHg (Goldman applanation) in either eye at screening. 6. Best corrected visual acuity worse than 20/320 in the study eye at screening or baseline. 7. Prior intra-ocular surgery in the study eye with the exception of uncomplicated cataract extraction more than 6 months prior to screening. 8. Laser photocoagulation in the study eye within three months prior to baseline. 9. Previous treatment with an intra-vitreal VEGF inhibitor or an intra-vitreal corticosteroid in the study eye within 6 months prior to screening. 10. Treatment with a topical or oral carbonic-anhydrase inhibitor within one month prior to baseline. 11. Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, hydrochloroquine, ethambutaol). 12. Patients with estimated glomerular filtration rate (GFR) 5.0 mmol/L at screening. 14. Any episodes of clinically significant hypoglycemia requiring medical intervention/ hospitalization within 3 months prior to screening. 15. 2 or more episodes of ketoacidosis within one year of screening. Patients with the latest episode of ketoacidosis within 3 months of screening will be excluded. 16. For normotensive patients, any history of clinically significant hypotension requiring medical attention within 12 months prior to screening. 17. Patients with heart failure NYHA class II-IV. 18. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening. 19. Second or third degree heart block without a pacemaker. Novartis Confidential Page 31 Protocol Amendment No. 4 Protocol No. CSPP100A2244 20. History or presence of cardiac arrhythmia within 6 months prior to screening that required antiarrhythmic drugs therapy. 21. Clinically significant valvular heart disease 22. Stroke within the 12 months prior to screening. 23. History of drug allergy or intolerance to aliskiren. 24. History of angioedema from ACE inhibitors, ARBs, or aliskiren therapy. 25. Patients with clinically significant thyroid dysfunction not controlled by any medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of aliskiren compared to placebo on change in central retina thickness (CRT), measured by optical coherence tomography (OCT), from the baseline thickness in patients with type 1 or type 2 diabetes, after 12 weeks of treatment.;Secondary Objective: To assess the effect of aliskiren on BCVA in terms of change from baseline in no. of letters correctly identified at 12 weeks;-on BCVA in terms of the proportion of patients with a = 15 letter gain or loss on BCVA at 12 weeks from baseline. To investigate relationship between change in macular edema and change in the RAS and angiogenic biomarkers. To assess effect of aliskiren on the percent of change in central retina thickness measured by optical coherence tomography from the baseline thickness that is above the lower limit of normal retina thickness in patients with type 1 or type 2 diabetes, after 12 weeks of treatment. To assess effect of aliskiren on change from baseline in central retinal thickness in terms of the proportion of patients with a = 75 micron decrease in CRT or a return to normal CRT, defined as no evidence of DME on OCT and a CRT of = 245 microns at 12 weeks from baseline.;Primary end point(s): change in central retina thickness from baseline thickness in patients with hypertension and type 1 and 2 diabetes after 12 weeks treatment change on BCVA - change from baseline in no of letters; with a = 15 letter gain or loss on the BCVA at 12 weeks from baseline | — |
Countries
Denmark
Outcome results
None listed