Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

November 16, 2011 updated by: Novartis

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

583

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Octreotide Acetate in Microspheres 20 mg
20 mg will be administered im once every 4 weeks
Drug: Octreotide Acetate in Microspheres 20 mg
Experimental: Octreotide Acetate in Microspheres 30 mg
30 mg will be administered im once every 4 weeks
Drug: Octreotide Acetate in Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to progression of diabetic retinopathy
Time Frame: throughout study
throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
time to development or progression of macular edema, and
Time Frame: Baseline through end of study
Baseline through end of study
time to moderate vision loss
Time Frame: Baseline through end of study
Baseline through end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis Customer Information, East Hanover

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 16, 2005

First Submitted That Met QC Criteria

August 16, 2005

First Posted (Estimate)

August 17, 2005

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMS995 0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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