Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
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)
2 other identifiers
interventional
312
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2000
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 15, 2005
CompletedFirst Posted
Study publicly available on registry
August 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedNovember 17, 2011
November 1, 2011
5.8 years
August 15, 2005
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to progression of diabetic retinopathy
Secondary Outcomes (2)
time to development or progression of macular edema,
time to moderate vision loss
Study Arms (2)
Octreotide Acetate in Microspheres
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis
East Hanover, New Jersey, 07936, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Customer Information
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2005
First Posted
August 16, 2005
Study Start
February 1, 2000
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
November 17, 2011
Record last verified: 2011-11