Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide Arm | Active Comparator | Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day. |
|
| Control Group | Placebo Comparator | The control group will receive a placebo nasal spray without the active ingredient, DDM-octreotide, and administering intranasally in one nostril three times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide (drug) | Drug | Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | up to one month |
| Changes in retinal capillary density | Each participant will have optical coherence tomography angiography and measure differences in retinal capillary density. | up to one month |
| Changes in retinal non-perfusion zones |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum insulin like growth factor -1 (IGF-1) levels | Each participant will have serum IGF-1 levels measured. | up to one month. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Medawar, MD | Contact | 256-682-4351 | nmedawar@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maria Grant, MD, FARVO | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35243 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015282 | Octreotide |
| D004364 | Pharmaceutical Preparations |
| C117975 | DDMS |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will administer the placebo nasal spray without priming in one nostril three times a day. |
|
Each participant will have optical coherence tomography angiography and measure differences in retinal non-perfusion zones. |
| up to one month |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |