Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131144
• Other study ID #: CSMS995 0802
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2005
• Last updated: November 16, 2011
• Start date: November 1999
• Est. completion date: December 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Octreotide Acetate in Microspheres 20 mg

• Octreotide Acetate in Microspheres

• Placebo

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression of diabetic retinopathy		throughout study	No
Secondary	time to development or progression of macular edema, and		Baseline through end of study	No
Secondary	time to moderate vision loss		Baseline through end of study	No