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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

Primary Purpose

Diabetic Retinopathy

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Octreotide acetate in microspheres

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic retinopathy, Octreotide acetate in microspheres

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Outcomes

Primary Outcome Measures

long-term safety and tolerability

Secondary Outcome Measures

monitor long-term efficacy

Full Information

NCT ID

NCT00248157

First Posted

November 2, 2005

Last Updated

April 30, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00248157

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Terminated

Why Stopped

Inconsistent treatment benefit

Study Start Date

November 2005 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

Diabetic retinopathy, Octreotide acetate in microspheres

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Octreotide acetate in microspheres

Primary Outcome Measure Information:

Title

long-term safety and tolerability

Secondary Outcome Measure Information:

Title

monitor long-term efficacy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

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