Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

What Was Tested

The trial (phase 3) is built around Octreotide for diabetic retinopathy and glaucoma.

It had two arms (groups): Octreotide Acetate in Microspheres (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

312 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 triple-blind.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the diabetic retinopathy and glaucoma participants stayed in one arm throughout.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2000-02 with completion listed for 2005-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: time to progression of diabetic retinopathy.

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

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 312 people with diabetic retinopathy and glaucoma.

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.