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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

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


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248131

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

No publications provided


Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00248131 History of Changes
Other Study ID Numbers:	CSMS9950802E1
Study First Received:	November 2, 2005
Last Updated:	April 8, 2012
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Novartis:


Diabetic retinopathy, octreotide acetate in microspheres

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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