Status:
COMPLETED
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Lead Sponsor:
Novartis
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ret...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT00131144
Start Date
November 1 1999
End Date
December 1 2005
Last Update
November 17 2011
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936