Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Octreotide

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