Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Octreotide Acetate in Microspheres
|
Drug: Octreotide Acetate in Microspheres
|
Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
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 []
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis | East Hanover | New Jersey | United States | 07936 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Chair: Customer Information, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSMS995 0804
- 59318