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Longer-Lasting eye injection could cut treatment visits for macular disease

NCT ID NCT07761039

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study looks at whether switching to a higher-dose eye injection called aflibercept 8 mg can allow people with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) to go longer between treatments. It follows adults in Portugal who have already had eye injections and are now switched to aflibercept 8 mg as part of their usual care. Researchers will track how long the effect lasts, how well vision holds up, and any side effects, using data from routine clinic visits.

What this could mean

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

Active substance
aflibercept 8 mg (intravitreal injection)
What this could lead to
If successful, this could show that aflibercept 8 mg allows longer intervals between eye injections for people with nAMD or DME, reducing treatment burden while keeping the disease in check.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and real-world variability. It does not prove cause and effect, and outcomes depend on routine clinical practice.

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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population comprises adult patients receiving routine ophthalmic care at participating centres in Portugal who have neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME), have previously received intravitreal therapy, and are switched to intravitreal aflibercept 8 mg according to the treating physician's clinical judgment and routine practice. Eligible eyes are enrolled consecutively from participating sites and followed using data collected during routine clinical care.

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: -Inclusion criteria - nAMD cohort 1. Diagnosis of neovascular age-related macular degeneration in the eye under treatment. 2. Patient aged ≥50 years at the time of the first aflibercept 8 mg injection. 3. The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study. 4. The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg. 5. Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation. Inclusion criteria - DME cohort 6. Diagnosis of diabetic macular edema in the eye under treatment, in a patient with established type 1 or type 2 diabetes mellitus. 7. Patient aged ≥18 years at the time of the first aflibercept 8 mg injection. 8. The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study. 9. The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg. 10. Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation. Exclusion Criteria applicable to both cohorts: 11. Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice. 12. Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg. 13. Active extra-ocular or peri-ocular infection or active intraocular inflammation in either eye at the time of the first switch-related aflibercept 8 mg injection. 14. Pre-existing ophthalmological condition in the eye under treatment (other than nAMD or DME) that, in the investigator's judgment, could materially affect the assessment of study outcomes - for example, advanced uncontrolled glaucoma, optic neuropathy or other retinal pathology. 15. Concomitant use of any medicinal product whose interaction with intravitreal aflibercept 8 mg, as listed in the locally approved Summary of Product Characteristics, would compromise the assessment of treatment effect or patient safety. 16. Prior intravitreal anti-VEGF treatment in the eye under treatment within the 28 days preceding the switch/index date. 17. Prior intravitreal corticosteroid administration in the eye under treatment within the 3 months preceding the switch/index date. 18. Fluocinolone acetonide intravitreal implant in the eye under treatment within the 3 years preceding the switch/index date. 19. Dexamethasone intravitreal implant in the eye under treatment within the 6 months preceding the switch/index date. 20. Any other concurrent drug-releasing intravitreal implant in the eye under treatment. 21. Pregnancy at the time of the first switch-related aflibercept 8 mg injection. Additional exclusion criterion - DME cohort only 22. Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.

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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.

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  1. The official record

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