NCT06881888

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Octreotide (drug)	Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
DRUG	Placebo	Participants will administer the placebo nasal spray without priming in one nostril three times a day.

Timeline

• Start date: 2026-08-31
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-18
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study