Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy
Phase 3
Terminated
- Conditions
- Diabetic Retinopathy
- Registration Number
- NCT00248131
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
- written informed consent provided prior to participation in the extension study
- successful completion of study CSMS995 0802
- willingness to comply with all study requirements
Exclusion Criteria
- more than 8 weeks interval since the completion of study CSMS995 0802
- premature discontinuation from study CSMS995 0802
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method long-term safety and tolerability
- Secondary Outcome Measures
Name Time Method monitor long-term efficacy