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The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide Acetate in Microspheres 20 mg | Experimental | 20 mg will be administered im once every 4 weeks |
|
| Octreotide Acetate in Microspheres 30 mg | Experimental | 30 mg will be administered im once every 4 weeks |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide Acetate in Microspheres 20 mg | Drug |
| ||
| Octreotide Acetate in Microspheres |
| Measure | Description | Time Frame |
|---|---|---|
| time to progression of diabetic retinopathy | throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| time to development or progression of macular edema, and | Baseline through end of study | |
| time to moderate vision loss | Baseline through end of study |
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Inclusion Criteria:
Males and females with type 1 and type 2 diabetes mellitus
Moderately severe or severe NPDR or mild PDR in at least one eye:
HbA1c < 13% at study entry
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Customer Information | East Hanover | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29116540 | Derived | Pivonello R, Muscogiuri G, Holder G, Paul M, Sarp S, Lesogor A, Jordaan P, Eisinger J, Colao A. Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies. Endocrine. 2018 Apr;60(1):65-72. doi: 10.1007/s12020-017-1448-5. Epub 2017 Nov 7. |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| D008863 | Microspheres |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Drug |
|
| Placebo | Drug |
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D004864 | Equipment and Supplies |