Visual ImpairmentNCT06075147
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 of Visual Impairment and Neovascular Age-related Macular Degeneration (nAMD), run by Bayer at 18 sites in 18 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macula Edema (DME)
- What is being tested?
- Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
- How many people
- 2,500 participants
- Where
- 18 sitesin 18 countries
- Study dates
- 15 Feb 2024to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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
- 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
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
Official title: An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting
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.
Read more
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.
- Conditions
- Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macula Edema (DME)
- Being tested
- Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)Drug
Following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| naïve nAMD | Treatment-naive patients with nAMD Receives: Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) | |
| pretreated nAMD | Pretreated patients with nAMD Receives: Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) | |
| naïve DME | Treatment-naïve patients with DME Receives: Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) | |
| pretreated DME | Pretreated patients with DME Receives: Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice
BCVA measurements at baseline (first injection of aflibercept 8 mg) and at 12 months as ETDRS letters (according to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or other methods (e.g. Snellen charts) used in the routine clinical practice in participating countries or sites (with conversion to ETDRS))
Measured: At baseline and 12 months
Secondary outcomes (6)
The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluated in routine clinical practice
Measured: At baseline, 4 weeks, 8 weeks, 6 months and 24 months
Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the second year (24 months), and the entire observation period (last visit), respectively
Performed intravitreal aflibercept 8 mg injections in study eye (including date)
Measured: Up to 24 months
Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 months treatment period
Performed different type of visits for study eye
Measured: Up to 24 months
Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 weeks, 6, 12, and 24 months
Measured: At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks, 6, 12, and 24 month follow up
Measured: At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Number of participants with (serious) adverse events and (serious) drug-related adverse events
Measured: From the first application of aflibercept 8 mg up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Feb 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075147
- Sponsor's protocol ID
- 22480
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting
- ClinicalTrials.gov ID
- NCT06075147
- Acronym / sponsor ID
- 22480
- Conditions
- Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macula Edema (DME)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| naïve nAMD | – | Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)Treatment-naive patients with nAMD |
| pretreated nAMD | – | Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)Pretreated patients with nAMD |
| naïve DME | – | Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)Treatment-naïve patients with DME |
| pretreated DME | – | Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)Pretreated patients with DME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)Following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines. | Drug | naïve DME, naïve nAMD, pretreated DME, pretreated nAMD |
Primary outcome
The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice
Time frame: At baseline and 12 months
BCVA measurements at baseline (first injection of aflibercept 8 mg) and at 12 months as ETDRS letters (according to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or other methods (e.g. Snellen charts) used in the routine clinical practice in participating countries or sites (with conversion to ETDRS))
6 secondary outcomes
The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluated in routine clinical practice
Time frame: At baseline, 4 weeks, 8 weeks, 6 months and 24 months
Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the second year (24 months), and the entire observation period (last visit), respectively
Time frame: Up to 24 months
Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 months treatment period
Time frame: Up to 24 months
Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 weeks, 6, 12, and 24 months
Time frame: At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks, 6, 12, and 24 month follow up
Time frame: At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Number of participants with (serious) adverse events and (serious) drug-related adverse events
Time frame: From the first application of aflibercept 8 mg up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Impairment and Neovascular Age-related Macular Degeneration (nAMD), run by Bayer at 18 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia, Canada, Denmark, Finland, France and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice (time frame: At baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.