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Octreotide in Microspheres

Phase 3

Diabetic Retinopathy | Small molecule | Ophthalmology |Novartis AG|Trials Updated: Nov 17, 2011

Octreotide in Microspheres target and mechanism

Molecular targetSSTR5, SSTR2, SSTR4, SSTR1, SSTR3
Target classAgonist
ModalitySmall molecule

Also known as Octreotide Acetate in Microspheres

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment895

FDA Designations

No designations recorded

Octreotide in Microspheres clinical trials

Octreotide in Microspheres · 2 trials · 1 indication

Phase 3 2
NCT00130845Octreotide Acetate in Microspheres in Patients With Diabetic RetinopathyDiabetic Retinopathy
COMPLETED312 Analytics
NCT00131144Octreotide Acetate in Microspheres in Patients With Diabetic RetinopathyDiabetic Retinopathy
COMPLETED583 Analytics
PHASE3COMPLETED
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Diabetic RetinopathyUnlock trial analytics
PHASE3COMPLETED
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Diabetic RetinopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

time to progression of diabetic retinopathy

Secondary Endpoints

time to development or progression of macular edema,
time to moderate vision loss
time to development or progression of macular edema, and
Baseline through end of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Octreotide Acetate in MicrospheresEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Octreotide Acetate in Microspheres 20 mgEXPERIMENTAL20 mg will be administered im once every 4 weeks
Octreotide Acetate in Microspheres 30 mgEXPERIMENTAL30 mg will be administered im once every 4 weeks

Interventions

NameTypeDescription
Octreotide Acetate in MicrospheresDRUG -
PlaceboDRUG -
Octreotide Acetate in Microspheres 20 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Competitive Landscape -Diabetic Retinopathy 14 trials

Frequently asked questions about Octreotide in Microspheres

What is Octreotide in Microspheres used for?

Octreotide in Microspheres is being developed for the treatment of diabetic retinopathy, an eye condition that can affect people with diabetes. It is an investigational therapy and has been studied in Phase 3 clinical trials. The drug is not approved for this use.

What does Octreotide in Microspheres target?

Octreotide in Microspheres targets somatostatin receptors SSTR1, SSTR2, SSTR3, SSTR4, and SSTR5. It acts as an agonist at these receptors. By binding to these targets, it is designed to modulate signaling pathways that may be involved in diabetic retinopathy.

Who is developing Octreotide in Microspheres?

Octreotide in Microspheres is being developed by Novartis AG, which trades under the ticker symbol NVS. Novartis is a global pharmaceutical company. The drug is in Phase 3 development for diabetic retinopathy.

What phase is Octreotide in Microspheres in?

Octreotide in Microspheres is in Phase 3 clinical development for diabetic retinopathy. Two Phase 3 trials have been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is Octreotide in Microspheres in?

Octreotide in Microspheres has been studied in two completed Phase 3 trials: NCT00131144, which enrolled 583 patients, and NCT00130845, which enrolled 312 patients. Both trials were conducted in the United States in adults with diabetic retinopathy. Both were randomized, double-blind, and placebo-controlled.

Is Octreotide in Microspheres the same as Octreotide Acetate in Microspheres?

Yes, Octreotide in Microspheres is also known as Octreotide Acetate in Microspheres. The 20 mg formulation is referred to as Octreotide Acetate in Microspheres 20 mg. These names refer to the same investigational product being developed by Novartis for diabetic retinopathy.