Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

What Was Tested

In this phase 3 trial, researchers set out to test Octreotide for diabetic retinopathy and glaucoma.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 583 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: condition which could interfere with the assessment of retinopathy progression; history of symptomatic gallstones without cholecystectomy; brittle diabetes or history of severe hypoglycemia unawareness.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the diabetic retinopathy and glaucoma participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 1999-11 with completion listed for 2005-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: time to progression of diabetic retinopathy (time frame: throughout study).

It also tracked 2 secondary outcomes, for example time to development or progression of macular edema, and and time to moderate vision loss.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 583 people with diabetic retinopathy and glaucoma.

With 583 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Diabetic retinopathy and glaucoma research.