Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130845
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : November 17, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Octreotide Acetate in Microspheres Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : February 2000
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Octreotide Acetate in Microspheres Drug: Octreotide Acetate in Microspheres
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. time to progression of diabetic retinopathy

Secondary Outcome Measures :
  1. time to development or progression of macular edema,
  2. time to moderate vision loss

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130845

United States, New Jersey
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Chair: Customer Information Novartis

Responsible Party: Novartis Identifier: NCT00130845     History of Changes
Other Study ID Numbers: CSMS995 0804
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by Novartis:
Diabetic retinopathy, Octreotide Acetate in Microspheres

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents