nAMDALLEVI8NCT07761039
Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME
An observational study of nAMD and DME, run by Grupo de Estudos da Retina.
Trial summary
The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Aflibercept 8mg
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2027
- 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: 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.
Who may be able to join
- -Inclusion criteria - nAMD cohort
- Diagnosis of neovascular age-related macular degeneration in the eye under treatment.
- Patient aged ≥50 years at the time of the first aflibercept 8 mg injection.
- 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.
- 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.
- 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.
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- Diagnosis of diabetic macular edema in the eye under treatment, in a patient with established type 1 or type 2 diabetes mellitus.
- Patient aged ≥18 years at the time of the first aflibercept 8 mg injection.
- 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.
- 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.
- 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.
Who cannot join
- Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice.
- Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg.
- 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.
- 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.
- 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.
- Prior intravitreal anti-VEGF treatment in the eye under treatment within the 28 days preceding the switch/index date.
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- Prior intravitreal corticosteroid administration in the eye under treatment within the 3 months preceding the switch/index date.
- Fluocinolone acetonide intravitreal implant in the eye under treatment within the 3 years preceding the switch/index date.
- Dexamethasone intravitreal implant in the eye under treatment within the 6 months preceding the switch/index date.
- Any other concurrent drug-releasing intravitreal implant in the eye under treatment.
- Pregnancy at the time of the first switch-related aflibercept 8 mg injection.
- Additional exclusion criterion - DME cohort only
- Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
António Campos, MD, PhD contact
About this study
Official title: Multicentre Observational Study to Investigate the Interval-Extension Potential, Effectiveness and Safety of Intravitreal Aflibercept 8 mg in Pretreated Eyes With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME) Under Routine Clinical Practice in Portugal
The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal.
It consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice.
Read more
The main questions it aims to answer are:
- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice?
Participants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.
- Being tested
- Aflibercept 8mg
- Keywords
- Neovascular age-related macular degeneration, Diabetic macular oedema, Aflibercept 8 mg, Interval extension, Real-world evidence, Treat-and-extend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept 8mgDrug
Intravitreal aflibercept 8 mg administered as part of routine clinical practice according to the locally approved prescribing information. Treatment initiation, dosing regimen, injection intervals, and treatment duration are determined by the treating physician independently of study participation. No study-specific treatment procedures or interventions are mandated by the protocol.
| Study group | Role | What they receive |
|---|---|---|
| nAMD Cohort | Pretreated eyes with neovascular age-related macular degeneration (nAMD) switched to intravitreal aflibercept 8 mg as part of routine clinical practice in Portugal. Treatment decisions, including the switch to aflibercept 8 mg and subsequent treatment intervals, are made independently of study participation. Participants are followed observationally using data collected during routine clinical care. This cohort includes eyes meeting all study eligibility criteria Receives: Drug: Aflibercept 8mg | |
| DME Cohort | Pretreated eyes with diabetic macular oedema (DME) switched to intravitreal aflibercept 8 mg as part of routine clinical practice in Portugal. Treatment decisions, including the switch to aflibercept 8 mg and subsequent treatment intervals, are made independently of study participation. Participants are followed observationally using data collected during routine clinical care. This cohort includes eyes meeting all study eligibility criteria. Receives: Drug: Aflibercept 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg
The last achieved treatment interval (days) following initiation of intravitreal aflibercept 8 mg, defined as the interval between the two most recent consecutive aflibercept 8 mg injections documented within each analysis window. The endpoint is summarized descriptively to evaluate the interval-extension potential under routine clinical practice.
Measured: Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).
Secondary outcomes (6)
Change in Best-Corrected Visual Acuity (BCVA)
Change in BCVA from baseline, measured in ETDRS letters, following initiation of intravitreal aflibercept 8 mg under routine clinical practice
Measured: Baseline, Months 6, 12, and 24 (if available)
Change in BCVA
Proportion of eyes achieving gains or losses of ≥5, ≥10, and ≥15 ETDRS letters from baseline.
Measured: Months 6, 12, and 24
Change in Central Retinal Thickness (CRT)
Change from baseline in central retinal thickness measured by optical coherence tomography (OCT).
Measured: Baseline, Months 6, 12, and 24
Retinal Fluid Status
Presence or absence of intraretinal fluid (IRF), subretinal fluid (SRF), and, where applicable, sub-retinal pigment epithelium (sub-RPE) fluid on OCT during follow-up.
Measured: Months 6, 12, and 24 (if available)
Number of Intravitreal Aflibercept 8 mg Injections
Number of intravitreal aflibercept 8 mg injections administered during follow-up as part of routine clinical practice.
Measured: Up to 24 months
Ocular and Systemic Safety
Incidence of ocular and systemic adverse events and serious adverse events reported during treatment with intravitreal aflibercept 8 mg under routine clinical practice.
Measured: From baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for nAMDStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos da Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761039
- Sponsor's protocol ID
- GER-001/2026
- Acronym
- ALLEVI8
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Observational Study to Investigate the Interval-Extension Potential, Effectiveness and Safety of Intravitreal Aflibercept 8 mg in Pretreated Eyes With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME) Under Routine Clinical Practice in Portugal
- ClinicalTrials.gov ID
- NCT07761039
- Acronym / sponsor ID
- ALLEVI8 / GER-001/2026
- Keywords
- Neovascular age-related macular degeneration, Diabetic macular oedema, Aflibercept 8 mg, Interval extension, Real-world evidence, Treat-and-extend
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grupo de Estudos da RetinaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2026 (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.
The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal.
It consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice.
The main questions it aims to answer are:
- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice?
Participants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nAMD Cohort | – | Drug: Aflibercept 8mgPretreated eyes with neovascular age-related macular degeneration (nAMD) switched to intravitreal aflibercept 8 mg as part of routine clinical practice in Portugal. Treatment decisions, including the switch to aflibercept 8 mg and subsequent treatment intervals, are made independently of study participation. Participants are followed observationally using data collected during routine clinical care. This cohort includes eyes meeting all study eligibility criteria |
| DME Cohort | – | Drug: Aflibercept 8mgPretreated eyes with diabetic macular oedema (DME) switched to intravitreal aflibercept 8 mg as part of routine clinical practice in Portugal. Treatment decisions, including the switch to aflibercept 8 mg and subsequent treatment intervals, are made independently of study participation. Participants are followed observationally using data collected during routine clinical care. This cohort includes eyes meeting all study eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- -Inclusion criteria - nAMD cohort
- Diagnosis of neovascular age-related macular degeneration in the eye under treatment.
- Patient aged ≥50 years at the time of the first aflibercept 8 mg injection.
- 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.
- 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.
Key exclusion criteria (13 listed)
- Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice.
- Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg.
- 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.
- 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.
- 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.
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 8mgIntravitreal aflibercept 8 mg administered as part of routine clinical practice according to the locally approved prescribing information. Treatment initiation, dosing regimen, injection intervals, and treatment duration are determined by the treating physician independently of study participation. No study-specific treatment procedures or interventions are mandated by the protocol. | Drug | DME Cohort, nAMD Cohort |
Primary outcome
Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg
Time frame: Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).
The last achieved treatment interval (days) following initiation of intravitreal aflibercept 8 mg, defined as the interval between the two most recent consecutive aflibercept 8 mg injections documented within each analysis window. The endpoint is summarized descriptively to evaluate the interval-extension potential under routine clinical practice.
6 secondary outcomes
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline, Months 6, 12, and 24 (if available)
Change in BCVA
Time frame: Months 6, 12, and 24
Change in Central Retinal Thickness (CRT)
Time frame: Baseline, Months 6, 12, and 24
Retinal Fluid Status
Time frame: Months 6, 12, and 24 (if available)
Number of Intravitreal Aflibercept 8 mg Injections
Time frame: Up to 24 months
Ocular and Systemic Safety
Time frame: From baseline to Month 24
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
António Campos, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of nAMD and DME, run by Grupo de Estudos da Retina.
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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Cláudia Farinha, MD, PhD (+351965635880, claudia.farinha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg (time frame: Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).). 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 12 Aug 2026.