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Aflibercept

Phase 2

Diabetic Retinopathy, DR | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Aug 5, 2026

Target and mechanism

ModalitySmall molecule

Also known as Aflibercept (EYLEA®)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Aflibercept · 1 trial · 1 indication

Phase 2 1
NCT05296447Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic RetinopathyDiabetic Retinopathy, DR
ENROLLING BY_INVITATION100 Analytics
PHASE2ENROLLING BY_INVITATION
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
NCT05296447100
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Study Endpoints

Primary Endpoints

Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)
5 years inclusive of the parent study

To evaluate the long-term safety of ABBV-RGX-314

Secondary Endpoints

Incidences of non-ocular AEs and any Adverse Events of Special Interest
5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography
5 years, inclusive of the parent study
Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
5 years, inclusive to the parent study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard of CareOTHERDose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration.
Supplemental TreatmentOTHERDL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye.

Interventions

NameTypeDescription
Standard of CareDRUGStandard of Care
AfliberceptDRUGInjection
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Must provide written, signed informed consent for this study * Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study * Must be willing and able t...

Countries:United States
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Competitive Landscape -Diabetic Retinopathy 7 trials (matched to "Diabetic Retinopathy, DR")

CompanyTickerTrialsLead PhaseDrugs
Ocular Therapeutix IncOCUL1PHASE3Single intravitreal of axitinib hydrogel followed by a mock procedure at Week 24, Intravitreal of axitinib hydrogel followed by a second intravitreal of the axitinib at Week 24
AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
Rhythm Pharmaceuticals, Inc.RYTM1 - Undisclosed
Adverum Biotechnologies, Inc.ADVM1 - ADVM-022
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Recent Changes (Last 90 Days)

MEDIUMAug 5, 2026NCT05296447Phase: null → PHASE2
LOWMay 26, 2026NCT05296447primaryCompletionDate: changed
LOWMay 24, 2026NCT05296447studyFirstPostDate: changed

Frequently asked questions about Aflibercept

What is Aflibercept used for in Diabetic Retinopathy?

Aflibercept (EYLEA®) is being studied for the treatment of Diabetic Retinopathy (DR), a complication of diabetes that affects the eyes. It is currently in Phase 2 clinical development for this indication, meaning it is still investigational and not yet approved for DR.

Who makes Aflibercept?

Aflibercept is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is also known by the brand name EYLEA®.

What phase is Aflibercept in for Diabetic Retinopathy?

Aflibercept is currently in Phase 2 clinical development for Diabetic Retinopathy. It is an investigational drug, meaning it has not yet received regulatory approval for this indication and is still being evaluated in clinical trials.

What clinical trials is Aflibercept in?

Aflibercept is being evaluated in a Phase 2 clinical trial with the identifier NCT05296447. This study is titled "Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy" and is enrolling 100 participants in the United States.

Is Aflibercept the same as EYLEA?

Yes, Aflibercept is also known as EYLEA®. The drug is being developed by AbbVie Inc. for the treatment of Diabetic Retinopathy and is currently in Phase 2 clinical trials.