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ranibizumab

Phase 3

Age-related Macular Degeneration | Monoclonal antibody | Ophthalmology |Outlook Therapeutics, Inc.|Last Updated: Jul 23, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment289
FDA Designations
No designations recorded
Clinical trial landscape

ranibizumab · 3 trials · 3 indications

Phase 3 3
NCT06190093A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)Neovascular Age-related Macular Degeneration
COMPLETED400 Analytics
NCT03834753A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)Age-related Macular Degeneration
COMPLETED228 Analytics
NCT03844074A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)Age-related Macular Degeneration
COMPLETED61 Analytics
PHASE3COMPLETED
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Neovascular Age-related Macular Degeneration
NCT06190093400
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PHASE3COMPLETED
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Age-related Macular Degeneration
NCT03834753228
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PHASE3COMPLETED
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Age-related Macular Degeneration
NCT0384407461
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Study Endpoints
Primary Endpoints
Evaluate the Effectiveness of Intravitreal Injections of ONS-5010 Compared to Ranibizumab in Preventing Vision Loss, as Measured by the Mean Change in Baseline Best Correct Visual Acuity (BCVA) at Week 8
Baseline, 8 weeks

BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.

Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
Baseline, 11 months

BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.

Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
Baseline, 11 months

BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.

Secondary Endpoints
Mean change in the best corrected visual acuity
Baseline, monthly to 11 months
Proportion of participants who gain at least 10 letters in the best corrected visual acuity
Baseline, 11 months
Proportion of participants who gain at least 5 letters in the best corrected visual acuity
Baseline, 11 months
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Study Design & Arms
AllocationNA
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ONS-5010 bevacizumabEXPERIMENTAL -
ranibizumabACTIVE_COMPARATOR -
bevacizumabEXPERIMENTALONS-5010
Interventions
NameTypeDescription
bevacizumabBIOLOGICAL1.25 mg, intravitreal injection
ranibizumabBIOLOGICAL0.5mg, intravitreal injection
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Eligibility Criteria
Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites61

Inclusion Criteria: * Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye * Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent) * Study eye must: * Have active leakage on Fluorescein A...

Countries:United StatesAustralia
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Competitive Landscape -Age-Related Macular Degeneration 31 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV7PHASE3Surabgene Lomparvovec, Ranibizumab Control
Ocular Therapeutix IncOCUL3PHASE3OTX-TKI, Aflibercept
4D Molecular Therapeutics, Inc.FDMT3PHASE34D-150 IVT, EYLEA
Regeneron Pharmaceuticals, Inc.REGN2PHASE3Aflibercept
EyePoint, Inc.EYPT2PHASE3EYP-1901, Aflibercept
Kodiak Sciences, Inc.KOD1PHASE3Tarcocimab tedromer, Tabirafusp tedromer, Aflibercept
Novartis AG Sponsored ADRNVS4PHASE2Iptacopan
Outlook Therapeutics, Inc.OTLK1PHASE3bevacizumab
Adverum Biotechnologies, Inc.ADVM4PHASE3Ixo-vec, Aflibercept
Apellis Pharmaceuticals, Inc.APLS1PHASE2APL-3007, pegcetacoplan
Johnson & JohnsonJNJ1PHASE2JNJ-81201887
Alcon AGALC1PHASE1AR-14034 lower dose, Aflibercept, Sham procedure
Sanofi SA Sponsored ADRSNY1PHASE1SAR402663, Diluent
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Recent Changes (Last 90 Days)
LOWJul 24, 2026NCT06190093lastUpdatePostDate: changed