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Double-Dose eye injections tested for two leading causes of blindness

NCT ID NCT06591598

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 study tested how much of the drug aflibercept gets into the bloodstream when a high dose (8 mg) is injected into both eyes of adults with diabetic macular edema or wet age-related macular degeneration. Fifty-one participants received the injections and had blood samples taken to measure drug levels. The goal was to gather more safety and exposure data, not to directly measure vision improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aflibercept (Eylea HD)
What this could lead to
If successful, this study could confirm that high-dose aflibercept is safe and effective when given to both eyes at once, potentially simplifying treatment for people with DME or wet AMD.
What could go wrong
This is a small, completed pharmacokinetic study (51 people) focused on drug levels, not on long-term safety or vision outcomes. Results may not apply to all patients or guarantee better vision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

51 people

The number who actually took part.

Started

Sep 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men or women ≥18 years of age (or country's legal age of adulthood if the legal age is \>18 years). * Participants (treatment naïve or previously treated) requiring intravitreal anti-vascular endothelial growth factor (VEGF) treatment in both eyes in the opinion of the investigator. * Participants with type 1 or type 2 diabetes mellitus and DME in both eyes with active central involvement (CI-DME) in at least one eye with central retinal thickness (CRT) ≥300 µm (or ≥320 µm on Spectralis) as determined by the investigator at the screening visit, OR diagnosis of nAMD in both eyes with active subfoveal choroidal neovascularization (CNV) in at least one eye with intraretinal fluid (IRF) and/or subretinal fluid (SRF) on OCT as determined by the investigator at the screening visit. * Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in eyes with active disease and decreased vision determined to be primarily the result of DME or nAMD. * A female participant is eligible to participate if she is not pregnant or breastfeeding. Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Exclusion Criteria: * Evidence of macular edema due to any cause other than diabetes mellitus in patients with DME or neovascular age-related macular degeneration in patients with nAMD in either eye. * Active proliferative diabetic retinopathy (DR) in either eye. * Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in either eye with CI-DME or active nAMD within 12 weeks (84 days) of the screening visit. * Prior treatment with intravitreal (IVT) 2 mg aflibercept (EYLEA) in either eye within 12 weeks (84 days) of the screening visit or with IVT 8 mg or HD aflibercept in either eye within 24 weeks (168 days) of the screening visit. * Prior treatment with any other approved IVT agent with anti-VEGF effect (e.g. ranibizumab, bevacizumab, brolucizumab, faricimab, pegaptanib sodium or biosimilars) in either eye within 4 weeks (28 days) of the screening visit. * Prior treatment with any ocular gene or cell therapy treatment in either eye. * Previous use of intraocular or periocular corticosteroids in either eye within 16 weeks (112 days) of the screening visit, or OZURDEX® implant within 180 days of the screening visit or ILUVIEN® or RETISERT® implant at any time

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Axon Clinical, s.r.o.

    Prague, 150 00, Czechia

  • Budapest Retina Associates

    Budapest, 1133, Hungary

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 012 07, Slovakia

  • Fakultní nemocnice Královské Vinohrady - Urologická klinikay

    Prague, 10034, Czechia

  • Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda

    Bratislava, 851 07, Slovakia

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