Recent Updates
Recently added Catalysts

Intravitreal Aflibercept

Phase 3

Diabetic Macular Edema | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 10, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment881
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01627249Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular EdemaPHASE3 COMPLETED 660 — — Aug 1, 2012Apr 18, 2019Aug 10, 202090 United States
NCT00789477DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical ImpactPHASE2 COMPLETED 221 — — Dec 1, 2008Sep 1, 2010Sep 9, 201447 United States, Austria +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year
Baseline to 1-year

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69
Baseline to 1-year

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69
Baseline to 1-year

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
At week 24

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

Secondary Endpoints
Overall Change in Optical Coherence Tomography Central Subfield Thickness
baseline to 1-year
Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69
baseline to 1-year
Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69
baseline to 1-year
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RanibizumabACTIVE_COMPARATOR -
AfliberceptEXPERIMENTAL -
BevacizumabEXPERIMENTAL -
Intravitreal Aflibercept Injection .5Q4EXPERIMENTALIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
Intravitreal Aflibercept Injection 2Q4EXPERIMENTALIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
Intravitreal Aflibercept Injection 2Q8EXPERIMENTALIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
Intravitreal Aflibercept Injection 2PRNEXPERIMENTALIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
Laser PhotocoagulationACTIVE_COMPARATORFocal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Interventions
NameTypeDescription
2.0 mg intravitreal afliberceptDRUGIntravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
1.25 mg intravitreal bevacizumabDRUGIntravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
0.3 mg intravitreal ranibizumabDRUGIntravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Laser PhotocoagulationPROCEDURElaser every 16 weeks as needed
Intravitreal Aflibercept InjectionDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites90

Inclusion Criteria: * Age ≥ 18 years * Individuals \<18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable. * Diagnosis of diabetes mellitus (type 1 or type 2) * Any one of the following will be considered to be sufficient evidenc...

Countries:United StatesAustriaCanada
Unlock Eligibility Criteria
Competitive Landscape -Diabetic Macular Edema 15 trials
CompanyTickerTrialsLead PhaseDrugs
EyePoint, Inc.EYPT2PHASE3EYP-1901, Aflibercept
Regeneron Pharmaceuticals, Inc.REGN1PHASE3Aflibercept
Oculis Holding AGOCS2PHASE3Dexamethasone, Vehicle
AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept
Outlook Therapeutics, Inc.OTLK1PHASE3bevacizumab
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
AlvotechALVO1PHASE3AVT29, Eylea HD
Kiora Pharmaceuticals, Inc.KPRX1PHASE2KIO-104
REGENXBIO, Inc.RGNX1PHASE2RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept
Ocugen IncOCGN1PHASE1OCU200
Adverum Biotechnologies, Inc.ADVM1 — ADVM-022
Unlock Competitive Intelligence