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Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Octreotide Acetate in Microspheres 20 mg
Octreotide Acetate in Microspheres
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic retinopathy,Octreotide Acetate in Microspheres

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Octreotide Acetate in Microspheres 20 mg

Octreotide Acetate in Microspheres 30 mg

Placebo

Arm Description

20 mg will be administered im once every 4 weeks

30 mg will be administered im once every 4 weeks

Outcomes

Primary Outcome Measures

time to progression of diabetic retinopathy

Secondary Outcome Measures

time to development or progression of macular edema, and
time to moderate vision loss

Full Information

First Posted
August 16, 2005
Last Updated
November 16, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00131144
Brief Title
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetic retinopathy,Octreotide Acetate in Microspheres

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
583 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Octreotide Acetate in Microspheres 20 mg
Arm Type
Experimental
Arm Description
20 mg will be administered im once every 4 weeks
Arm Title
Octreotide Acetate in Microspheres 30 mg
Arm Type
Experimental
Arm Description
30 mg will be administered im once every 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Octreotide Acetate in Microspheres 20 mg
Intervention Type
Drug
Intervention Name(s)
Octreotide Acetate in Microspheres
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
time to progression of diabetic retinopathy
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
time to development or progression of macular edema, and
Time Frame
Baseline through end of study
Title
time to moderate vision loss
Time Frame
Baseline through end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Customer Information
Organizational Affiliation
East Hanover
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29116540
Citation
Pivonello R, Muscogiuri G, Holder G, Paul M, Sarp S, Lesogor A, Jordaan P, Eisinger J, Colao A. Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies. Endocrine. 2018 Apr;60(1):65-72. doi: 10.1007/s12020-017-1448-5. Epub 2017 Nov 7.
Results Reference
derived

Learn more about this trial

Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

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