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Anecortave sterile

Phase 3

Macular Degeneration | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 1, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment1,061

FDA Designations

No designations recorded

Clinical trial landscape

Anecortave sterile · 3 trials · 5 indications

Phase 3 3
NCT00051129Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)Macular Degeneration
COMPLETED291 Analytics
NCT00299507Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)Macular Degeneration
COMPLETED240 Analytics
NCT00041483Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMDMacular Degeneration
COMPLETED530 Analytics
PHASE3COMPLETED
Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)
Macular DegenerationUnlock trial analytics
PHASE3COMPLETED
Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)
Macular DegenerationUnlock trial analytics
PHASE3COMPLETED
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD
Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in logMAR visual acuity score at 12 months
Month 12
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
Month 12
Percentage of Patients Maintaining Vision
Month 12

Secondary Endpoints

Mean change in lesion growth at Month 12 from baseline
Month 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anecortave AcetateEXPERIMENTALPosterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
Anecortave Acetate VehiclePLACEBO_COMPARATORPosterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
15 mg Anecortave Acetate, 3 month intervalsEXPERIMENTALAnecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months).
15 mg Anecortave Acetate, 6 month intervalsEXPERIMENTALAnecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
30 mg Anecortave Acetate, 6 month intervalsEXPERIMENTALAnecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
Anecortave and Sham PDTACTIVE_COMPARATOR -
PDT and Sham Anecortave AcetateACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Anecortave Acetate 15 mg sterile suspensionDRUG0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
Anecortave Acetate VehicleOTHERAdministered as a posterior juxtascleral injection
Anecortave Acetate Sterile Suspension, 30 mg/mLDRUGOne 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
Anecortave Acetate Sterile Suspension, 60 mg/mLDRUGOne 0.5 mL posterior juxtascleral depot injection at 6 month intervals
Photodynamic Therapy (PDT)OTHER -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Under 50 years. * Other protocol-defined exclusion criteria may apply.

Countries:United States
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Frequently asked questions about Anecortave sterile

What is Anecortave Sterile,mL used for?

Anecortave Sterile,mL is an investigational small molecule being developed by Alcon Inc. for ophthalmology indications, including open-angle glaucoma, eye diseases, and macular degeneration. It has been studied in clinical trials for subfoveal choroidal neovascularization due to wet age-related macular degeneration and for open-angle glaucoma.

Who makes Anecortave Sterile,mL?

Anecortave Sterile,mL is being developed by Alcon Inc., a company traded under the ticker ALC. The drug is an investigational small molecule in the ophthalmology therapeutic area.

What phase is Anecortave Sterile,mL in?

Anecortave Sterile,mL is currently in Phase 2 clinical development. It has completed three clinical trials, including one Phase 3 trial for wet age-related macular degeneration and multiple Phase 2 trials for open-angle glaucoma. The drug is investigational and not approved.

What clinical trials has Anecortave Sterile,mL been in?

Anecortave Sterile,mL has been studied in three completed trials. NCT00051129 was a Phase 3 trial in wet age-related macular degeneration with 291 participants. NCT00320203 and NCT00451152 were Phase 2 trials in open-angle glaucoma, and NCT00691717 was a Phase 2 trial in open-angle glaucoma or ocular hypertension.

Is Anecortave Sterile,mL the same as anecortave acetate?

Anecortave Sterile,mL is the drug name used in clinical trial records, and the trials refer to the study drug as anecortave acetate. The clinical trials listed under the drug name Anecortave Sterile,mL investigate anecortave acetate as the active agent.

How does Anecortave Sterile,mL work?

Anecortave Sterile,mL is a small molecule being studied for its effects in ophthalmology conditions such as open-angle glaucoma and macular degeneration. The specific molecular target of the drug has not been disclosed in the available clinical trial information.