Back to resultsOctreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Octreotide Acetate in Microspheres
Placebo
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: Males and females with type 1 and type 2 diabetes mellitus Moderately severe or severe NPDR or mild PDR in at least one eye: with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of > 35 letters; and not previously treated with scatter photocoagulation. HbA1c < 13% at study entry Exclusion Criteria: Condition which could interfere with the assessment of retinopathy progression History of symptomatic gallstones without cholecystectomy Brittle diabetes or history of severe hypoglycemia unawareness Previous treatment with a somatostatin analogue
Sites / Locations
- Novartis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Octreotide Acetate in Microspheres
Placebo
Arm Description
Outcomes
Primary Outcome Measures
time to progression of diabetic retinopathy
Secondary Outcome Measures
time to development or progression of macular edema,
time to moderate vision loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00130845
Brief Title
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Official Title
A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octreotide Acetate in Microspheres
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Octreotide Acetate in Microspheres
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
time to progression of diabetic retinopathy
Secondary Outcome Measure Information:
Title
time to development or progression of macular edema,
Title
time to moderate vision loss
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:
Males and females with type 1 and type 2 diabetes mellitus
Moderately severe or severe NPDR or mild PDR in at least one eye:
with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of > 35 letters; and
not previously treated with scatter photocoagulation.
HbA1c < 13% at study entry
Exclusion Criteria:
Condition which could interfere with the assessment of retinopathy progression
History of symptomatic gallstones without cholecystectomy
Brittle diabetes or history of severe hypoglycemia unawareness
Previous treatment with a somatostatin analogue
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Customer Information
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
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