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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 )

November 2, 2005
November 3, 2005
April 10, 2012
November 2005
July 2006   (Final data collection date for primary outcome measure)
long-term safety and tolerability
Not Provided
Complete list of historical versions of study NCT00248131 on ClinicalTrials.gov Archive Site
monitor long-term efficacy
Not Provided
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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
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetic Retinopathy
Drug: Octreotide acetate in microspheres
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
260
Not Provided
July 2006
July 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00248131
CSMS9950802E1
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

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