Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Phase 3

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Octreotide Acetate in Microspheres 20 mg; Drug: Octreotide Acetate in Microspheres; Drug: Placebo

• Registration Number: NCT00131144
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2005-08-16
• Study First Submitted QC: 2005-08-16
• Study First Posted: 2005-08-17
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 583

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octreotide Acetate in Microspheres 20 mg	Octreotide Acetate in Microspheres 20 mg	20 mg will be administered im once every 4 weeks
Octreotide Acetate in Microspheres 30 mg	Octreotide Acetate in Microspheres	30 mg will be administered im once every 4 weeks
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
time to progression of diabetic retinopathy	throughout study

Secondary Outcome Measures

Name	Time	Method
time to development or progression of macular edema, and	Baseline through end of study
time to moderate vision loss	Baseline through end of study

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States