Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Phase 3
Completed
- Conditions
- Diabetic Retinopathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT00130845
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 312
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Octreotide Acetate in Microspheres Octreotide Acetate in Microspheres - Placebo Placebo -
- Primary Outcome Measures
Name Time Method time to progression of diabetic retinopathy
- Secondary Outcome Measures
Name Time Method time to development or progression of macular edema, time to moderate vision loss
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States