Moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathy
Conditions
Interventions
Trade Name: Sandostatin LAR
Product Code: SMS995
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: octreotide
Current S
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. written informed consent provided prior to participation in the extension study 2. successful completion of study CSMS995 0802 3. willingness to comply with all study requirements 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. more than 8 weeks interval since the completeion of study CSMS995 0802 2. premature discontinuation from study CSMS995 0802
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the long-term safety and tolerability of open-label treatment with Sandostatin LAR 30 mg in patients who completed the double-masked study CSMS995 0802; Secondary Objective: To monitor the long-term efficacy of open-label treatment with Sandostatin LAR 30 mg To alow patients who have completed study CSMS995 0802 to continue receiving treatment with Sandostatin LAR until regulatory approval is obtained ;Primary end point(s): To assess the rates of adverse events (AEs) and serious adverse events (SAEs), as well as changes in laboratory values, gallbladder ultrasound, ECG and vital signs and flagging of clinically notable lab/vital sign values | — |
Countries
Austria, Czech Republic, Denmark, Finland, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed