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Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00131144
First received: August 16, 2005
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  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 20 mg
Drug: Octreotide Acetate in Microspheres
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • time to progression of diabetic retinopathy [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to development or progression of macular edema, and [ Time Frame: Baseline through end of study ] [ Designated as safety issue: No ]
  • time to moderate vision loss [ Time Frame: Baseline through end of study ] [ Designated as safety issue: No ]

Enrollment: 583
Study Start Date: November 1999
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo

  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, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Customer Information East Hanover
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00131144     History of Changes
Other Study ID Numbers: CSMS995 0802
Study First Received: August 16, 2005
Last Updated: November 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013