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Proliferative Diabetic Retinopathy (PDR)Phase 4HERONCT07118670

High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes

A Phase 4 study testing Aflibercept 8mg in people with Proliferative Diabetic Retinopathy (PDR), run by Edward Wood, MD at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Proliferative Diabetic Retinopathy (PDR)
What is being tested?
Aflibercept 8mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
8 Dec 2025to Apr 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • Blood pressure > /=180/100 mmHg systolic/ diastolic, while seated
  • Pregnant or breastfeeding women
  • Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/ baseline; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly, or total abstinence).
  • Contraception is not required for men with documented vasectomy
  • Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Retina Consultants of Texas - Austin Retina Associates

    Austin, Texas, 78705

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: A 96-week, Single-arm Study to Evaluate the Efficacy and Safety of 8mg Aflibercept in Subjects With Proliferative Diabetic Retinopathy (PDR) Without Center-involved Diabetic Macular Edema (DME)

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.

Read the detailed description

Subjects will be administered intravitreal aflibercept 8mg every 4 weeks, starting at week 0 for 8 weeks, then may be extended by 4-week intervals with no maximum between treatments with an end of study visit at week 96. At any visit, it will be determined if supplemental treatment is needed as determined by disease activity assessment until there is no regression of disease is noted and the extension intervals will begin again.

Being tested
Aflibercept 8mg
Keywords
HERO, PDR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept 8mgDrug

    Also called Eylea HD, 8 mg Aflibercept, Aflibercept High Dose VEGF Trap-Eye

    Solution in Vial, intravitreal (IVT) injection

Study groups in NCT07118670
Study groupRoleWhat they receive
All subjectsExperimentalSubjects 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.
Receives: Drug: Aflibercept 8mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline through weeks 48 and 96

Secondary outcomes (11)

  1. DRSS Step Improvement

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

    Measured: Baseline to week 24 and 96

  2. Mean change in BCVA

    Evaluate the mean change in the best corrected visual acuity (BCVA)

    Measured: Baseline through weeks 24, 48, 72, and 96

  3. Conversion from PDR to NPDR

    Proportion of eyes converting from proliferative diabetic retinopathy (PDR) to non-proliferative diabetic retinopathy (NPDR)

    Measured: Baseline to weeks 24, 48, 72, 96.

  4. DRSS Step Improvement

    Proportion of eyes with >= 3 step improvement in diabetic retinopathy severity scale (DRSS)

    Measured: Baseline to weeks 24, 48, 72, 96

  5. Retinal non-perfusion change

    Mean change (quantitative area) in retinal vascular non-perfusion (RNP) based on ultrawide-field fluorescein angiography (UWFA)

    Measured: Baseline to weeks 24, 48, 72, 96.

  6. Changes in visual function on HVF

    Mean change in Humphrey visual field 30-2 total point score

    Measured: Baseline to weeks 48, 96.

  7. CST change

    Mean change in CST

    Measured: Baseline to weeks 24, 48, 72, 96

  8. Number of supplemental treatments

    Mean and median number of intravitreal (IVT) 8mg aflibercept injections (with and without intravitreal 8 mg aflibercept injections given for DME) as well as annualized injection frequencies

    Measured: Baseline through week 96

  9. Worsening PDR

    Time to first worsening of proliferative diabetic retinopathy associated event(s), including PDR-related vitrectomy, new or worsening preretinal or vitreous hemorrhage, retinal detachment, panretinal photocoagulation (time-to-event analysis)

    Measured: Baseline to week 96

  10. CI-DME development

    ·Time to first development of central-involved DME (CI-DME) defined as > 320 µm in the study eye (time-to-event analysis)

    Measured: Baseline to week 96

  11. AEs notated

    Incidence and severity of ocular and systemic adverse events

    Measured: Baseline to week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start8 Dec 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118670
Sponsor's protocol ID
VGFTe(HD)-DR-24143
Acronym
HERO
Status last verified
Mar 2026
First submitted
29 Jul 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept 8mg in people with Proliferative Diabetic Retinopathy (PDR), run by Edward Wood, MD at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint - DRSS step improvement (time frame: Baseline through weeks 48 and 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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