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

Novartis

Status and phase: Terminated; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Octreotide acetate in microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT00248157

CSMS995 0804E1

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)