NCT00131144

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
583

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

6.1 years

First QC Date

August 16, 2005

Last Update Submit

November 16, 2011

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy,Octreotide Acetate in Microspheres

Outcome Measures

Primary Outcomes (1)

  • time to progression of diabetic retinopathy

    throughout study

Secondary Outcomes (2)

  • time to development or progression of macular edema, and

    Baseline through end of study

  • time to moderate vision loss

    Baseline through end of study

Study Arms (3)

Octreotide Acetate in Microspheres 20 mg

EXPERIMENTAL

20 mg will be administered im once every 4 weeks

Drug: Octreotide Acetate in Microspheres 20 mg

Octreotide Acetate in Microspheres 30 mg

EXPERIMENTAL

30 mg will be administered im once every 4 weeks

Drug: Octreotide Acetate in Microspheres

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Octreotide Acetate in Microspheres 20 mgDRUG
Octreotide Acetate in Microspheres 20 mg
Octreotide Acetate in MicrospheresDRUG
Octreotide Acetate in Microspheres 30 mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • 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.

    PMID: 29116540DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

OctreotideMicrospheres

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsEquipment and Supplies

Study Officials

  • Novartis Customer Information

    East Hanover

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

November 1, 1999

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

US(1)