Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 16, 2005

Last Updated Date

June 7, 2006

Start Date ^†

November 1999

Current Primary Outcome Measures ^†

time to progression of diabetic retinopathy

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00131144 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

time to development or progression of macular edema, and
time to moderate vision loss

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

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)

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetic Retinopathy

Intervention ^†

Drug: Octreotide Acetate in Microspheres

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

540

Completion Date

Primary Completion Date

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

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00131144

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis Customer Information

East Hanover

Information Provided By

Novartis

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.