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:

ClinicalTrials.gov Identifier:

NCT00248131

First Posted: November 3, 2005

Last Update Posted: April 10, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Purpose

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.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: Octreotide acetate in microspheres	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

long-term safety and tolerability

Secondary Outcome Measures:

monitor long-term efficacy


Estimated Enrollment:	260
Study Start Date:	November 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248131

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00248131 History of Changes
Other Study ID Numbers:	CSMS9950802E1
First Submitted:	November 2, 2005
First Posted:	November 3, 2005
Last Update Posted:	April 10, 2012
Last Verified:	April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Diabetic retinopathy, octreotide acetate in microspheres

Additional relevant MeSH terms:


Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications	Diabetes Mellitus Endocrine System Diseases Octreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents

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