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

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00248131

First received: November 2, 2005

Last updated: April 8, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2005

Last Updated Date

April 8, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

long-term safety and tolerability

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00248131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

monitor long-term efficacy

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Retinopathy

Intervention ^ICMJE

Drug: Octreotide acetate in microspheres

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

260

Completion Date

July 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00248131

Other Study ID Numbers ^ICMJE

CSMS9950802E1

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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