Clinical Trial: Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Diabet
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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: time to progression of diabetic retinopathy [ Time Frame: throughout study ]
Original Primary Outcome:
Current Secondary Outcome:
- time to development or progression of macular edema, and [ Time Frame: Baseline through end of study ]
- time to moderate vision loss [ Time Frame: Baseline through end of study ]
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: August 16, 2005
Date Started: November 1999
Date Completion:
Last Updated: November 16, 2011
Last Verified: November 2011
