Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Novartis583 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

583

Conditions

Diabetic Retinopathy

Interventions

Octreotide Acetate in Microspheres 20 mgDRUG

Octreotide Acetate in MicrospheresDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

time to progression of diabetic retinopathy

Time frame: throughout study

Secondary Outcomes

time to development or progression of macular edema, and

Time frame: Baseline through end of study

time to moderate vision loss

Time frame: Baseline through end of study

Data from ClinicalTrials.gov

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