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Octreotide in Microspheres · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Octreotide Acetate in Microspheres | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
| Name | Type | Description |
|---|---|---|
| Octreotide Acetate in Microspheres | DRUG | - |
| Placebo | DRUG | - |
| Octreotide Acetate in Microspheres 20 mg | DRUG | - |
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: * with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of \> 35 letters; and * not previously treated with scatter photocoagul...
Octreotide in Microspheres is an investigational small molecule being developed for diabetic retinopathy, a complication of diabetes that affects the eyes. It is administered as microspheres, a formulation designed to release the drug slowly over time. The drug is currently in Phase 3 clinical development.
Octreotide in Microspheres is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with diabetic retinopathy.
Octreotide in Microspheres is in Phase 3 clinical development for diabetic retinopathy. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, but the drug remains under investigation and is not yet available commercially.
Octreotide in Microspheres has been studied in two completed Phase 3 clinical trials: NCT00130845, which enrolled 312 patients, and NCT00131144, which enrolled 583 patients. Both trials were conducted in the United States and included adult patients with diabetic retinopathy. The trials were randomized, double-blind, and placebo-controlled.
Octreotide in Microspheres is a small molecule that works by mimicking the action of somatostatin, a hormone that inhibits the release of growth hormone and other factors. In diabetic retinopathy, this mechanism is thought to reduce abnormal blood vessel growth in the retina, although the exact pathway is not fully detailed in the available information.