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OpenTrials
Completed

NCT Number: NCT00131144

Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octreotide Acetate in Microspheres 20 mg

Drug

Octreotide Acetate in Microspheres

Drug

Placebo

Drug

Primary outcomes

  1. time to progression of diabetic retinopathy

    Time frame: throughout study

Secondary outcomes

  1. time to development or progression of macular edema, and

    Time frame: Baseline through end of study

  2. time to moderate vision loss

    Time frame: Baseline through end of study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
1999
Primary completion
2005
Study completion
2005
First posted
Aug 17, 2005
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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