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.