High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes

NCT07118670 | Active Not Recruiting Phase 4

• 1 other identifier: VGFTe(HD)-DR-24143
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this Phase 4 study is to evaluate the safety of aflibercept 8mg in patients with proliferative diabetic retinopathy without center-involved diabetic macular edema.

Conditions

Proliferative Diabetic Retinopathy (PDR)

Keywords

HERO; PDR

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint - DRSS step improvement

  Proportion of eyes with ≥ 2 step improvement in diabetic retinopathy severity scale (DRSS), as assessed by the central reading center

  Baseline through weeks 48 and 96

Secondary Outcomes (11)

• DRSS Step Improvement

  Baseline to week 24 and 96

• Mean change in BCVA

  Baseline through weeks 24, 48, 72, and 96

• Conversion from PDR to NPDR

  Baseline to weeks 24, 48, 72, 96.

• DRSS Step Improvement

  Baseline to weeks 24, 48, 72, 96

• Retinal non-perfusion change

  Baseline to weeks 24, 48, 72, 96.

Study Arms (1)

All subjects

EXPERIMENTAL

Subjects will receive 8mg aflibercept at week 0, 4, and 8. At week 12, subjects will enter a variable treatment and extension approach where they may be extended by 4-week intervals with no maximum interval between treatments until the end of study visit at week 96. Supplemental: Disease activity will be assessed at every 4-week visit and supplemental treatment with panretinal photocoagulation (PRP) as needed and/or intravitreal (IVT) 8mg aflibercept injections as determined by the regression patterns listed below. No regression: administer IVT aflibercept 8mg at 4-week intervals. If NV is not assessable due to VH, continue IVT and reassess; PRP is deferred. Supplemental PRP permitted ONLY if NV is assessable AND "No Regression" persists after prespecified treatment thresholds. Partial regression: Continue IVT aflibercept 8mg. Continue monthly observation. PRP not permitted. Total Regression: Without IVT aflibercept 8mg. Continue monthly observation. PRP not permitted.

Drug: Aflibercept 8mg

Interventions

Aflibercept 8mg DRUG

Solution in Vial, intravitreal (IVT) injection

Also known as: Eylea HD, 8 mg Aflibercept, Aflibercept High Dose VEGF Trap-Eye

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Men or women \> 18 years of age at the time of signing the Informed Consent Form
• Diagnosed with type 1 or type 2 diabetes mellitus
• BCVA ETDRS \>/= 20/400 in the study eye
• Any Proliferative Diabetic Retinopathy as diagnosed via clinical examination and fluorescein angiography

You may not qualify if:

• Any known hypersensitivity to any of the components of aflibercept 8 mg injection
• Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used bye the site during the study
• Prior systemic anti-VEGF or IVT anti-VEGF treatment in the study eye within 3 months of enrollment. (i.e., 3-month (90 days) wash-out period for anti-VEGF allowed)
• Any intra- or periocular corticosteroid treatment in the study eye within 3 months (90 days) of baseline
• Any intraocular sustained-release treatment or implantable device in the study eye
• Any gene therapy in the study eye
• SD-OCT central subfield thickness measurement of \> 320 µm, in the study eye
• Evidence of ocular infection, in the study eye, at time of screening
• IOP \>/= 25 mmHg in the study eye
• Any intraocular inflammation/ infection in either eye within 12 weeks (84 days) of the screening visit
• History of vitreoretinal surgery in the study eye
• Any prior Panretinal laser photocoagulation (PRP) in the study eye
• Current vitreous hemorrhage obscuring clear view of the macula in the study eye (precluding baseline imaging and DRSS grading)
• Presence of any tractional retinal detachment (macular or peripheral) or pre-retinal fibrovascular proliferation (macular or peripheral) causing definite retinal traction or elevation (e.g. retinal tenting/peaking, tractional folds, or OCT-confirmed tractional distortion) in the study eye. Pre-retinal fibrovascular tissue without evidence of retinal traction or elevation (macular or peripheral) is permitted
• Cataract surgery in the study eye within 4 weeks prior to Screening/ Day 0

Sponsors & Collaborators

• Edward Wood, MD: lead
• Greater Houston Retina Research: collaborator

Study Sites (3)

Retina Consultants of Texas - Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas - San Antonio

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Edward Wood, MD

  Retina Consultants of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 12, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)