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anecortave

Phase 3

Macular Degeneration | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Nov 29, 2012

anecortave target and mechanism

ModalitySmall molecule

Also known as anecortave acetate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment276

FDA Designations

No designations recorded

anecortave clinical trials

anecortave · 4 trials · 5 indications

Phase 3 1Phase 2 2Phase 1 1
NCT00058994An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal CNV Due to Exudative AMDMacular Degeneration
COMPLETED- Analytics
PHASE3COMPLETED
An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal CNV Due to Exudative AMD
Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from the baseline in logMAR visual acuity score at Month 6
Mean change in logMAR visual acuity at 12 months from baseline.
12 months
Percentage of patients requiring glaucoma filtering surgery
3 years

Secondary Endpoints

% patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV.
Percentage of patients requiring topical glaucoma medication
3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anecortave Acetate 30EXPERIMENTAL -
Anecortave Acetate 15EXPERIMENTAL -
Anecortave Acetate 3EXPERIMENTAL -
Anecortave Acetate VehiclePLACEBO_COMPARATOR -
1ACTIVE_COMPARATOR50 mgs of anecortave acetate (0.5 ml of a 10% suspension)
2ACTIVE_COMPARATORPatients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)
3ACTIVE_COMPARATORPatients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)
4ACTIVE_COMPARATORPatients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension)

Interventions

NameTypeDescription
anecortave acetateDRUG -
Anecortave acetate 30 mgDRUG0.5ml administered onto the sclera once every six months for 24 months
Anecortave Acetate 15 mgDRUG0.5ml administered onto the sclera once every six months for 24 months
Anecortave Acetate 3 mgDRUG0.5ml administered onto the sclera once every six months for 24 months
Anecortave Acetate VehicleOTHER0.5ml administered onto the sclera once every six months for 24 months
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Patients at least 50 years of age, of any race, and either sex with a clinical diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.

Countries:United States
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Frequently asked questions about anecortave

What is anecortave used for?

Anecortave is an investigational ophthalmology drug studied for age-related macular degeneration (AMD), including exudative AMD, and for posterior uveitis. Clinical trials have evaluated it in patients with subfoveal choroidal neovascularization due to exudative AMD and as prophylactic treatment in patients with a Retisert implant.

Who is developing anecortave?

Anecortave is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company, and anecortave is part of its ophthalmology pipeline.

What phase is anecortave in?

Anecortave is in Phase 2 development. It has been studied in completed Phase 1, Phase 2, and Phase 3 clinical trials, but it is not approved and remains investigational.

What clinical trials is anecortave in?

Anecortave has been studied in completed trials including NCT00570479, a Phase 1 study of prophylactic anecortave acetate in patients with a Retisert implant; NCT00346957, a Phase 2 study in exudative AMD; NCT00346866, a Phase 2 study versus placebo in AMD patients following PDT; and NCT00058994, a Phase 3 study in subfoveal CNV due to exudative AMD.

Is anecortave the same as anecortave acetate?

Yes, anecortave is also known as anecortave acetate, and it has been referred to as anecortave acetate 30 mg in some contexts. These names refer to the same investigational compound.