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 3TerminatedNCT00248131

Novartis Pharmaceuticals260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Diabetic Retinopathy

Interventions

Octreotide acetate in microspheresDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes