Diabetic Retinopathy
Conditions
Keywords
Diabetic retinopathy,Octreotide Acetate in Microspheres
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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression of diabetic retinopathy | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| time to development or progression of macular edema, and | Baseline through end of study |
| time to moderate vision loss | Baseline through end of study |
Countries
United States
Outcome results
None listed