Extension Study of the 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
Primary Purpose
Diabetic Retinopathy
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Octreotide acetate in microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic retinopathy, Octreotide acetate in microspheres
Eligibility Criteria
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CSMS995 0804 willingness to comply with all study requirements Exclusion Criteria: more than 8 weeks interval since the completion of study CSMS995 0804 premature discontinuation from study CSMS995 0804 Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
long-term safety and tolerability
Secondary Outcome Measures
monitor long-term efficacy
Full Information
NCT ID
NCT00248157
First Posted
November 2, 2005
Last Updated
April 30, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00248157
Brief Title
Extension Study of the 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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Inconsistent treatment benefit
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetic retinopathy, Octreotide acetate in microspheres
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Octreotide acetate in microspheres
Primary Outcome Measure Information:
Title
long-term safety and tolerability
Secondary Outcome Measure Information:
Title
monitor long-term efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
written informed consent provided prior to participation in the extension study
successful completion of study CSMS995 0804
willingness to comply with all study requirements
Exclusion Criteria:
more than 8 weeks interval since the completion of study CSMS995 0804
premature discontinuation from study CSMS995 0804
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Extension Study of the 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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