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CompletedNCT00130845Updated Nov 17, 2011

Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

A Phase 3 interventional study of Octreotide Acetate in Microspheres and Placebo in Diabetic Retinopathy, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-11-17.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Retinopathy

Keywords

  • Diabetic retinopathy, Octreotide Acetate in Microspheres
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 312 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
312 participants (actual)

Study arms

  • Experimental
    Octreotide Acetate in Microspheres

    Drug: Octreotide Acetate in Microspheres

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugOctreotide Acetate in Microspheres
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. time to progression of diabetic retinopathy

Secondary outcomes

  1. time to development or progression of macular edema,

  2. time to moderate vision loss

07

Study locations

1 site
  • Novartis
    East Hanover, New Jersey 07936, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00130845
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Aug 16, 2005
Start date
Feb 2000
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Nov 17, 2011

Study contacts

Customer Information
study chair · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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