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RGX-314 Dose 1

Phase 2

Diabetic Macular Edema | Gene therapy | Ophthalmology |REGENXBIO Inc.|Last Updated: Apr 24, 2025

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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
RMATORPHAN_DRUGRARE_PEDIATRIC_DISEASEFAST_TRACKACCELERATED_APPROVALPRIORITY_REVIEW
Clinical trial landscape

RGX-314 Dose 1 · 1 trial · 1 indication

Phase 2 1
NCT06942520Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)Diabetic Macular Edema
RECRUITING18 Analytics
PHASE2RECRUITING
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
Diabetic Macular Edema
NCT0694252018
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Study Endpoints
Primary Endpoints
Mean change from baseline in BCVA in the study eye at Week 52
52 Weeks

To evaluate the effect of RGX-314 on BCVA at Week 52

Secondary Endpoints
Mean change from baseline in BCVA in the study eye over time
52 Weeks
Proportion of participants with BCVA of 20/40 or better (ETDRS ≥ 69 letters) in the study eye over time
52 Weeks
Mean change from baseline in central subfield thickness (CST) in the study at week 52
52 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RGX-314 Treatment Arm (Dose 1)EXPERIMENTALGenetic: RGX-314 Dose 1 \- AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
Treatment Arm (Dose 2)EXPERIMENTALGenetic: RGX-314 Dose 2 -AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
Aflibercept Treatment ArmACTIVE_COMPARATORBiological: Aflibercept IVT * Commercially available Active Comparator * Other Names: Eylea
Interventions
NameTypeDescription
RGX-314 Dose 1GENETICAAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
RGX-314 Dose 2GENETICAAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
Aflibercept (2.0 mg)BIOLOGICALCommercially available Active Comparator
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Eligibility Criteria
Age Range25 Years to 89 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment * HbA1c ≤12% * BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening * Decreased visual acuity attributable primarily due to CI - DME * Demonstrate clin...

Countries:United States
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Competitive Landscape -Diabetic Macular Edema 15 trials
CompanyTickerTrialsLead PhaseDrugs
EyePoint, Inc.EYPT2PHASE3EYP-1901, Aflibercept
Oculis Holding AGOCS2PHASE3Dexamethasone, Vehicle
Regeneron Pharmaceuticals, Inc.REGN1PHASE3Aflibercept
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
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06942520primaryCompletionDate: changed
LOWMay 24, 2026NCT06942520studyFirstPostDate: changed