Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

What Was Tested

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

This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802.

During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 105 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: Written informed consent provided prior to participation in the extension study. Successful completion of study CSMS995 0804. Willingness to comply with all study requirements.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: more than 8 weeks interval since the completion of study csms995 0804; premature discontinuation from study csms995 0804.

How the Study Was Run

Design: randomized, single-group and open-label.

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

Being open-label, the Octreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-11 with completion listed for 2006-05.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: long-term safety and tolerability.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 105 people with diabetic retinopathy and glaucoma.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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