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Anecortave Sterile, mL

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Anecortave sterile

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, mL · 7 trials · 8 indications

Phase 3 3Phase 2 4
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
Mean Intraocular Pressure at 8 am
Up to 6 months
Mean Intraocular Pressure (IOP)
3 months
Mean change in intraocular pressure at 9 am from baseline
Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
Mean change in IOP at Week 4 from Baseline
Week 4

Secondary Endpoints

Mean change in lesion growth at Month 12 from baseline
Month 12
Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)
Month 3, 8 am
Percent Treatment Failures
3 months
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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 -
24 mg Anecortave AcetateEXPERIMENTALAnecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye
48 mg Anecortave AcetateEXPERIMENTALAnecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye
60 mg Anecortave AcetateEXPERIMENTALAnecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye
Anecortave Acetate DepotEXPERIMENTAL -
Anecortave Acetate 3 mg DepotEXPERIMENTALSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate 15 mg DepotEXPERIMENTALSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate 30 mg DepotEXPERIMENTALSingle injection, anterior juxtascleral depot (AJD)

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 -
Anecortave Acetate Sterile Suspension, 75 mg/mLDRUGSingle administration by anterior juxtascleral depot
Anecortave Acetate Sterile Suspension, 6 mg/mLDRUGSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate Suspension Depot, 30 mg/mLDRUGOne 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
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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 StatesBrazilHungaryItalyNetherlandsPuerto RicoSpainUnited Kingdom
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Frequently asked questions about Anecortave Sterile, mL

What is Anecortave Sterile?

Anecortave Sterile is an investigational small molecule eye medication developed by Alcon Inc. (ticker ALC). It is formulated as a sterile suspension and has been studied in Phase 2 clinical trials for ophthalmology conditions including open-angle glaucoma, ocular hypertension, eye diseases, and macular degeneration.

What is Anecortave Acetate Sterile Suspension used for?

Anecortave Acetate Sterile Suspension has been studied in Phase 2 trials for open-angle glaucoma, ocular hypertension, steroid induced intraocular pressure elevation, eye diseases, and macular degeneration. It is an investigational therapy and is not approved for commercial use.

Who makes Anecortave Sterile?

Anecortave Sterile is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical trial program evaluating the sterile suspension in patients with open-angle glaucoma, ocular hypertension, and related eye conditions.

What phase is Anecortave Sterile in?

Anecortave Sterile is in Phase 2 clinical development. All three of its listed trials are Phase 2 studies, and all have been completed. The program has enrolled a total of 1,061 participants across randomized, double-blind, controlled trials.

What clinical trials is Anecortave Sterile in?

Anecortave Sterile has been evaluated in completed Phase 2 trials including NCT00691717 in open-angle glaucoma or ocular hypertension, NCT00451152 in open-angle glaucoma, NCT00320203 in open-angle glaucoma, and NCT00315640 in steroid induced intraocular pressure elevation. These studies enrolled 201, 89, 86, and 70 participants respectively.

Is Anecortave Sterile the same as Anecortave Acetate Sterile Suspension?

Yes. Anecortave Sterile is also known as Anecortave Acetate Sterile Suspension, available in 6 mg/mL and 30 mg/mL strengths, as well as Anecortave Acetate 15 mg sterile suspension. These names refer to the same Alcon investigational product studied in Phase 2 eye disease trials.