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NCT06075147Active, not recruiting

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
4 Oct 2023
Start date
15 Feb 2024
Primary completion date
30 Sept 2027
Lead sponsor
Bayer
NCT number
NCT06075147

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 15 Feb 2024 to the primary completion date, 30 Sept 2027
  • 18 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Extra/periocular infection or inflammation in either eye at time of first injection
  • Extra/periocular infection or inflammation in either eye at time of first injection

Other

  • 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
  • Participation in an investigational program with interventions outside of clinical routine practice
  • Contraindications as listed in the intravitreal aflibercept 8 mg local product information

Who the study is looking for

  • 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)
  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Multiple LocationsUnited Arab EmiratesUnknown status
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Multiple LocationsAustraliaUnknown status
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Multiple LocationsCanadaUnknown status
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Multiple LocationsSwitzerlandUnknown status
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Multiple LocationsGermanyUnknown status
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Multiple LocationsDenmarkUnknown status
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Multiple LocationsSpainUnknown status
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Multiple LocationsFinlandUnknown status
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Multiple LocationsFranceUnknown status
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Multiple LocationsUnited KingdomUnknown status
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Multiple LocationsItalyUnknown status
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Multiple LocationsJapanUnknown status
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Multiple LocationsSouth KoreaUnknown status
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Multiple LocationsNetherlandsUnknown status
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Multiple LocationsNorwayUnknown status
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Multiple LocationsPortugalUnknown status
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Multiple LocationsSaudi ArabiaUnknown status
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Multiple LocationsSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.