Study to Assess the Efficacy and Safety of Monthly Octreotide Intramuscular Injections in Patients With Proliferative Diabetic Retinopathy After Lasercoagulation This Study is Not Being Conducted in the United States.

What Was Tested

This registered phase 3 trial tested Octreotide for diabetic retinopathy and glaucoma.

Phase III study comparing monthly octreotide i.m. in comparison to no additional treatment in patients with proliferative diabetic retinopathy after lasercoagulation.

The registry classes the interventions as drug.

Who Took Part

17 planned participants were the target.

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: Patients with type-I or type-II-diabetes mellitus. Males or females aged 18 - 70 years. Media clarity, pupillary dilation and patient cooperation sufficient to allow stereoscopic 30°, or equivalent, fundus photographs of adequate quality in at least one eye that meets criterion #3 above. Starting of photocoagulation of at least one eye to treat PDR in between approximately 2 weeks prior to start of study. Systolic blood pressure \< 180 mm Hg and diastolic blood pressure \< 105 mm Hg at study entry.

The full record lists 12 inclusion and 9 exclusion criteria; among the exclusions: pretreatment as panretinal laser treatment other than photocoagulation which started approximately 2 weeks prior to start of study (see inclusion criteria # 5); patients with a history of symptomatic gallstones who have not had a cholecystectomy (patients with asymptomatic cholelithiasis may be entered); patients with a history of severe hypoglycemia unawareness.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-12 with completion listed for 2006-05.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: regression of neovascularization.

It also tracked 1 secondary outcome, for example Determine tolerability and safety.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 17 people with diabetic retinopathy and glaucoma.

Its size is small, so on its own it can only give an early look.

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.