Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT00131144

Run by

Novartis

People needed

583

Starts

1999-11-01

Expected to finish

2005-12-01

Last updated by the study team

2011-11-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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