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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
Participants will administer the placebo nasal spray without priming in one nostril three times a day.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Change in macular central subfield thickness
Participants will have an optical coherence tomography at each visit that will measure macular central subfield thickness. Measuring the change at their baseline appointment and each additional study visit.
Time frame: Up to one month.
Change in best corrected visual acuity
Each participant will have best corrected visual acuity measured by Early Treatment of Diabetic Retinopathy study (ETDRS) chart. Enter the full scale.
Time frame: Up to one month.
Change in microglia on retinal surface
Each participant will have an optical coherence tomography angiography scan measuring the quantity of microglia on the retinal surface.
Time frame: Up to one month
Changes in retinal peripheral capillary free zone
Each participant will have optical coherence tomography angiography and measure differences in retinal peripheral capillary free zone.
Time frame: up to one month
Changes in retinal foveal avascular zone
Each participant will have optical coherence tomography angiography and measure differences in retinal foveal avascular zone.
Time frame: up to one month
Changes in retinal capillary density
Each participant will have optical coherence tomography angiography and measure differences in retinal capillary density.
Time frame: up to one month
Changes in retinal non-perfusion zones
Each participant will have optical coherence tomography angiography and measure differences in retinal non-perfusion zones.
Time frame: up to one month
Changes in serum insulin like growth factor -1 (IGF-1) levels
Each participant will have serum IGF-1 levels measured.
Time frame: up to one month.
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