Project terminated due to loss of sponsor funding following the dissolution of AMD Opti.
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.
Age range 18-90
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.
Written informed consent is provided.
Males and females
History of difficult to control diabetes or hypertension
Eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months.
Eye having undergone YAG capsulotomy in the last 3 months.
Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
Parallel
Octreotide (drug)
DrugParticipants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
Placebo
DrugParticipants will administer the placebo nasal spray without priming in one nostril three times a day.
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.
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.
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.
Changes in retinal peripheral capillary free zone
Each participant will have optical coherence tomography angiography and measure differences in retinal peripheral capillary free zone.
Changes in serum insulin like growth factor -1 (IGF-1) levels
Each participant will have serum IGF-1 levels measured.
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