Extension Study of the Long-Term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-Proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00248157

Purpose

This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.

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, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-Proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)

Further study details as provided by Novartis:

Primary Outcome Measures:

long-term safety and tolerability

Secondary Outcome Measures:

monitor long-term efficacy

Estimated Enrollment:	160
Study Start Date:	November 2005

Eligibility

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

Criteria

Inclusion Criteria:

written informed consent provided prior to participation in the extension study
successful completion of study CSMS995 0804
willingness to comply with all study requirements

Exclusion Criteria:

more than 8 weeks interval since the completion of study CSMS995 0804
premature discontinuation from study CSMS995 0804

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248157

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Customer Information

Novartis

More Information

Study ID Numbers:	CSMS995 0804E1
Study First Received:	November 2, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00248157
Health Authority:	United States: Food and Drug Administration

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 14, 2009