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Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

NCT ID: NCT00131144

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

583 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2005-12-31

Brief Summary

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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 Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Octreotide Acetate in Microspheres 20 mg

20 mg will be administered im once every 4 weeks

Group Type EXPERIMENTAL

Octreotide Acetate in Microspheres 20 mg

Intervention Type DRUG

Octreotide Acetate in Microspheres 30 mg

30 mg will be administered im once every 4 weeks

Group Type EXPERIMENTAL

Octreotide Acetate in Microspheres

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Octreotide Acetate in Microspheres 20 mg

Intervention Type DRUG

Octreotide Acetate in Microspheres

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Customer Information

Role: STUDY_CHAIR

East Hanover

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29116540 (View on PubMed)

Other Identifiers

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CSMS995 0802

Identifier Type: -

Identifier Source: org_study_id