The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in… (NCT06075147) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Additio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since SPECTRUM is an observational study rather than a treatment trial, does that mean I would receive aflibercept 8 mg as part of my normal care regardless, and the study is simply watching how well it works in real-world practice — and if so, what would actually change about my appointments or data collection?
2The study is actively enrolling patients but is no longer recruiting, so is there any realistic chance I could still be included, or should we focus entirely on other treatment paths?
3Because this is a real-world observational study rather than a controlled clinical trial, what does my doctor already know about how aflibercept 8 mg compares to other available treatments for my specific condition — either nAMD or diabetic macular edema — based on the evidence gathered so far?
4The main thing this study is measuring is change in best corrected visual acuity over 12 months, but what other factors — like injection frequency, side effects, or quality of life — should we be tracking together as part of my care, whether or not I'm connected to this study?
5Would my doctor consider aflibercept 8 mg an appropriate option for my situation right now, and if not, what would need to be different about my diagnosis or treatment history before it might be worth discussing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice