Double-Dose eye injections tested for two leading causes of blindness
NCT ID NCT06591598
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic macular edema are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer eye injections dry the retina in wet AMD?
- The 20-Minute squeeze: how eye injections push pressure up
- Could years of eye injections weigh down the upper eyelid?
- Eye implant takes aim at diabetic macular edema
- One shot in the eye: gene therapy aims to replace repeated injections for wet AMD
- Can a One-Time gene injection ease the burden of wet AMD?