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Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema
Sponsor: University of Alabama at Birmingham
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.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-31
Completion Date
2027-12
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Octreotide (drug)
Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
Placebo
Participants will administer the placebo nasal spray without priming in one nostril three times a day.
Locations (1)
The University of Alabama at Birmingham
Birmingham, Alabama, United States