drugset / Trial / NCT06881888

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

NCT06881888

Phase 1 Not yet recruiting 60 enrolled University of Alabama at Birmingham
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-08-31
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Octreotide Peptide Intranasal