Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Real-World check: does aflibercept 8 mg hold up outside the lab?

NCT ID NCT06075147

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This observational study will follow 2,500 adults with vision loss from nAMD or DME who are already prescribed aflibercept 8 mg by their doctors. Researchers will collect data from routine visits over up to 24 months to see how vision changes. The goal is to understand how well the drug works in real-world settings, not in a controlled trial.

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 (eye injection)
What this could lead to
If successful, this study will provide real-world evidence on how well aflibercept 8 mg works for vision loss due to nAMD and DME, supporting its use in routine care.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection or other factors. It does not test a new treatment but gathers data on an already approved drug.

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 2,500 people

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

Started

Feb 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

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.

Who is studied

SPECTRUM will be performed in eye clinics and ophthalmology practices in several countries across North America, Europe, Middle East, and Asia Pacific. Female and male patients (aged ≥ 18 years for the DME cohorts or ≥ 50 years for the nAMD cohorts) with a diagnosis of nAMD or DME can be enrolled after the decision for treatment with aflibercept 8 mg has been made by the treating physician. Indications, contraindications, risks, warnings, and precautions according to the local market authorization/local product information should be carefully considered. For each patient a single eye will be considered as a study eye. The eye treated with aflibercept 8 mg will be considered as study eye. If treatment for both eyes is decided simultaneously, the study eye will be the worse eye as per discretion of the treating physician. Treatment of the 2nd eye will be considered as a concomitant treatment.

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 for patients with nAMD * A diagnosis of nAMD * Patient aged ≥50 years * Patients for whom the decision to initiate treatment with intravitreal (IVT) aflibercept 8 mg according to a local product information was made as part of routine clinical practice * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws) Inclusion criteria for patients with DME * A diagnosis of DME * Patient aged ≥18 years (or country's legal age of adulthood if the legal age is \>18 years) with type 1 or type 2 diabetes mellitus * Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws) Exclusion Criteria: Exclusion criteria for all patients with nAMD * Participation in an investigational program with interventions outside of clinical routine practice * Contraindications as listed in the local intravitreal aflibercept 8 mg local product information * Extra/periocular infection or inflammation in either eye at time of first injection * Patient receiving other intravitreal treatments other than aflibercept in the fellow eye * Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8 mg local product information Additional exclusion criteria for treatment-naïve patients with nAMD * Any prior ocular treatment in the study eye or systemic treatment in nAMD Additional exclusion criteria for pretreated patients with nAMD * Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days * Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months * Fluocinolone implant in the study eye within the last 3 years * Dexamethasone implant in the study eye within the last 6 months * Any concurrent drug releasing implant in the study eye Exclusion criteria for all patients with DME * Participation in an investigational program with interventions outside of clinical routine practice * Contraindications as listed in the intravitreal aflibercept 8 mg local product information * Extra/periocular infection or inflammation in either eye at time of first injection * Patient receiving other intravitreal treatments other than aflibercept in the fellow eye * Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8 mg local product information * Previous treatment of the study eye with laser in the last 90 days prior to first IVT aflibercept 8 mg Additional exclusion criteria for treatment-naïve patients with DME * Any prior ocular treatment in the study eye or systemic treatment in DME Additional exclusion criteria for pretreated patients with DME * Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days * Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months * Fluocinolone implant in the study eye within the last 3 years * Dexamethasone implant in the study eye within the last 6 months * Any concurrent drug releasing implant in the study eye

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetic macula edema (DME) are added.

Vår säkerhetsrekommendation!

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

  • Many Locations

    Multiple Locations, Australia

  • Many Locations

    Multiple Locations, Canada

  • Many Locations

    Multiple Locations, Denmark

  • Many Locations

    Multiple Locations, Finland

  • Many Locations

    Multiple Locations, France

  • Many Locations

    Multiple Locations, Germany

  • Many Locations

    Multiple Locations, Italy

  • Many Locations

    Multiple Locations, Japan

  • Many Locations

    Multiple Locations, Netherlands

  • Many Locations

    Multiple Locations, Norway

  • Many Locations

    Multiple Locations, Portugal

  • Many Locations

    Multiple Locations, Saudi Arabia

  • Many Locations

    Multiple Locations, South Korea

  • Many Locations

    Multiple Locations, Spain

  • Many Locations

    Multiple Locations, Sweden

  • Many Locations

    Multiple Locations, Switzerland

  • Many Locations

    Multiple Locations, United Arab Emirates

  • Many Locations

    Multiple Locations, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.