Overview

Extension Study of the 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

Status:
Terminated
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Octreotide
Criteria
Inclusion Criteria:

- written informed consent provided prior to participation in the extension study

- successful completion of study CSMS995 0804

- willingness to comply with all study requirements

Exclusion Criteria:

- more than 8 weeks interval since the completion of study CSMS995 0804

- premature discontinuation from study CSMS995 0804

Other protocol-defined inclusion/exclusion criteria may apply.