An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)

Novartis Pharmaceuticals0 sites260 target enrollmentNovember 2005

ConditionsDiabetic Retinopathy

DrugsOctreotide acetate in microspheres

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetic Retinopathy
Sponsor: Novartis Pharmaceuticals
Enrollment: 260
Primary Endpoint: long-term safety and tolerability
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

July 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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