- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00131144
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
November 16, 2011 updated by: Novartis
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
583
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Novartis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Octreotide Acetate in Microspheres 20 mg
20 mg will be administered im once every 4 weeks
|
|
Experimental: Octreotide Acetate in Microspheres 30 mg
30 mg will be administered im once every 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to progression of diabetic retinopathy
Time Frame: throughout study
|
throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to development or progression of macular edema, and
Time Frame: Baseline through end of study
|
Baseline through end of study
|
time to moderate vision loss
Time Frame: Baseline through end of study
|
Baseline through end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis Customer Information, East Hanover
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1999
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
August 16, 2005
First Submitted That Met QC Criteria
August 16, 2005
First Posted (Estimate)
August 17, 2005
Study Record Updates
Last Update Posted (Estimate)
November 17, 2011
Last Update Submitted That Met QC Criteria
November 16, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSMS995 0802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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