Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00131144
• Collaborator: (none)
• Enrollment: 583
• Location: 1
• Arms: 3
• Duration (Months): 73
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: Octreotide Acetate in Microspheres 20 mg; Drug: Octreotide Acetate in Microspheres; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 583 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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)
• Study Start Date: Nov 1, 1999
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. time to progression of diabetic retinopathy [throughout study]

Secondary Outcome Measures

1. time to development or progression of macular edema, and [Baseline through end of study]

2. time to moderate vision loss [Baseline through end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis	East Hanover	New Jersey	United States	07936

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis Customer Information, East Hanover

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00131144
• Other Study ID Numbers: CSMS995 0802
• First Posted: Aug 17, 2005
• Last Update Posted: Nov 17, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Novartis: Diabetic retinopathy,Octreotide Acetate in Microspheres
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Octreotide

Study Results

No Results Posted as of Nov 17, 2011