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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

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ClinicalTrials.gov Identifier: NCT00248131
Recruitment Status : Terminated
First Posted : November 3, 2005
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Octreotide acetate in microspheres Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 260 participants
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)
Study Start Date : November 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. long-term safety and tolerability

Secondary Outcome Measures :
  1. monitor long-term efficacy

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00248131     History of Changes
Other Study ID Numbers: CSMS9950802E1
First Posted: November 3, 2005    Key Record Dates
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