Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00131144

Purpose

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.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: Octreotide Acetate in Microspheres	Phase III

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Novartis:

Primary Outcome Measures:

time to progression of diabetic retinopathy

Secondary Outcome Measures:

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

Estimated Enrollment:	540
Study Start Date:	November 1999

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131144

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Customer Information

East Hanover

More Information

Study ID Numbers:	CSMS995 0802
Study First Received:	August 16, 2005
Last Updated:	June 7, 2006
ClinicalTrials.gov Identifier:	NCT00131144
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Diabetic retinopathy,Octreotide Acetate in Microspheres

Study placed in the following topic categories:

Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Octreotide

Endocrine System Diseases
Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Gastrointestinal Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009