A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)

Novartis1 site in 1 country583 target enrollmentNovember 1999

ConditionsDiabetic Retinopathy

InterventionsOctreotide Acetate in Microspheres 20 mg Octreotide Acetate in Microspheres Placebo

DrugsOctreotide Acetate in Microspheres 20 mg Octreotide Acetate in Microspheres Placebo

Overview

Phase: Phase 3
Intervention: Octreotide Acetate in Microspheres 20 mg
Conditions: Diabetic Retinopathy
Sponsor: Novartis
Enrollment: 583
Locations: 1
Primary Endpoint: time to progression of diabetic retinopathy
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1999

End Date

December 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility 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