A open-label extension study to evaluate the long-term safety and tolerability of Sandostatin LAR in the treatment of patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathy
- Conditions
- Moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathy
- Registration Number
- EUCTR2004-004696-11-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 217
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
1. more than 8 weeks interval since the completeion of study CSMS995 0802
2. premature discontinuation from study CSMS995 0802
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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
- Secondary Outcome Measures
Name Time Method