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AL-39324

Phase 2

Age Related Macular Degeneration | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Jul 18, 2014

AL-39324 target and mechanism

ModalitySmall molecule

Also known as AL-39324 ophthalmic suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

AL-39324 clinical trials

AL-39324 · 1 trial · 1 indication

Phase 2 1
NCT00992563WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment ExaminationAge Related Macular Degeneration
COMPLETED35 Analytics
PHASE2COMPLETED
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
Age Related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of targeted adverse events occurring in the study eye
Up to Day 7 after injection

Secondary Endpoints

Mean change from baseline in central foveal thickness (CFT) at Month 1
Baseline (Day 0), Month 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AL-39324 Concentration Level AEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level BEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level CEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level DEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
AL-39324 Concentration Level EEXPERIMENTALAL-39324 ophthalmic suspension, single intravitreal injection
LucentisACTIVE_COMPARATORRanibizumab 10 mg/mL solution, single intravitreal injection

Interventions

NameTypeDescription
AL-39324 ophthalmic suspensionDRUG -
Ranibizumab 10 mg/mLDRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Willing to give written informed consent, make the required study visits and follow instructions; * The study eye: * must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD; * lesion must be no larger than 30 mm2; * must have edema measuring...

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Frequently asked questions about AL-39324

What is AL-39324?

AL-39324 is an investigational small molecule developed by Alcon Inc. (ticker: ALC) for the treatment of age-related macular degeneration (AMD). It is formulated as an ophthalmic suspension and has been studied in a Phase 2 clinical trial. AL-39324 is not approved for any indication and remains in clinical development.

What is AL-39324 used for in age-related macular degeneration?

AL-39324 is being developed for the treatment of age-related macular degeneration (AMD), a leading cause of vision loss. It is intended for patients with the wet form of AMD, as studied in the WALTZ trial. The drug is investigational and has not been approved for any use.

Who makes AL-39324?

AL-39324 is developed by Alcon Inc., which trades under the ticker symbol ALC. Alcon is an eye care company focused on ophthalmic products. The company is responsible for the clinical development of AL-39324.

What phase is AL-39324 in?

AL-39324 is in Phase 2 clinical development. A single Phase 2 trial has been completed. The drug is investigational and has not been approved by the FDA or any regulatory agency for any indication.

What clinical trials is AL-39324 in?

AL-39324 has been studied in one completed Phase 2 clinical trial, NCT00992563, also known as the WALTZ trial. The trial enrolled 35 participants with age-related macular degeneration and was randomized, double-blind, and active-controlled. No active trials of AL-39324 are currently listed.

Is AL-39324 the same as AL-39324 ophthalmic suspension?

Yes, AL-39324 ophthalmic suspension is another name for AL-39324. The ophthalmic suspension refers to the formulation of the small molecule developed by Alcon Inc. for age-related macular degeneration. Both names refer to the same investigational drug.