Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Placebo; Drug: Octreotide Acetate in Microspheres 20 mg; Drug: Octreotide Acetate in Microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131144

CSMS995 0802

Details and patient eligibility

About

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.

Enrollment: 583 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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583 participants in 3 patient groups, including a placebo group

Octreotide Acetate in Microspheres 20 mg

Experimental group

Description:

20 mg will be administered im once every 4 weeks

Treatment:

Drug: Octreotide Acetate in Microspheres 20 mg

Octreotide Acetate in Microspheres 30 mg

Experimental group

Description:

30 mg will be administered im once every 4 weeks

Treatment:

Drug: Octreotide Acetate in Microspheres

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo