Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema
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.
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age range 18-90 2. 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. 3. Written informed consent is provided. 4. Males and females 5. Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits. Exclusion Criteria: 1. History of difficult to control diabetes or hypertension 2. Eyes receiving laser photocoagulation in the last 6 months or in…
Interventions
- DrugOctreotide (drug)
Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
- DrugPlacebo
Participants will administer the placebo nasal spray without priming in one nostril three times a day.
Location
- The University of Alabama at BirminghamBirmingham, Alabama