Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

What Was Tested

This registered phase 1 trial tested Octreotide.

Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids.

It had two arms (groups): Octreotide Arm (active comparator) and Control Group (placebo comparator).

Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day.

The control group will receive a placebo nasal spray without the active ingredient, DDM-octreotide, and administering intranasally in one nostril three times a day.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Age range 18-90. Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200. Written informed consent is provided. Males and females. Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits.

The full record lists 5 inclusion and 24 exclusion criteria; among the exclusions: history of difficult to control diabetes or hypertension; eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months; eye having undergone yag capsulotomy in the last 3 months.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

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

It started in 2026-08-31 with completion listed for 2026-10-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in macular central subfield thickness (time frame: Up to one month). Change in best corrected visual acuity (time frame: Up to one month). Change in microglia on retinal surface (time frame: Up to one month).

It also tracked 1 secondary outcome, for example Changes in serum insulin like growth factor -1 (IGF-1) levels.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.