DME, nAMD
Conditions
Keywords
Neovascular age-related macular degeneration, Diabetic macular oedema, Aflibercept 8 mg, Interval extension, Real-world evidence, Treat-and-extend
Brief 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. 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.
Interventions
DRUGAflibercept 8mg
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.
Sponsors
Grupo de Estudos da Retina
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Inclusion criteria - nAMD cohort 1. Diagnosis of neovascular age-related macular degeneration in the eye under treatment. 2. Patient aged ≥50 years at the time of the first aflibercept 8 mg injection. 3. 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. 4. 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. 5. 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. Inclusion criteria - DME cohort 6. Diagnosis of diabetic macular edema in the eye under treatment, in a patient with established type 1 or type 2 diabetes mellitus. 7. Patient aged ≥18 years at the time of the first aflibercept 8 mg injection. 8. 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. 9. 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. 10. 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.
Exclusion criteria
applicable to both cohorts: 11. Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice. 12. Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg. 13. 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. 14. 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. 15. 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. 16. Prior intravitreal anti-VEGF treatment in the eye under treatment within the 28 days preceding the switch/index date. 17. Prior intravitreal corticosteroid administration in the eye under treatment within the 3 months preceding the switch/index date. 18. Fluocinolone acetonide intravitreal implant in the eye under treatment within the 3 years preceding the switch/index date. 19. Dexamethasone intravitreal implant in the eye under treatment within the 6 months preceding the switch/index date. 20. Any other concurrent drug-releasing intravitreal implant in the eye under treatment. 21. Pregnancy at the time of the first switch-related aflibercept 8 mg injection. Additional exclusion criterion - DME cohort only 22. Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) | Baseline, Months 6, 12, and 24 (if available) | Change in BCVA from baseline, measured in ETDRS letters, following initiation of intravitreal aflibercept 8 mg under routine clinical practice |
| Change in BCVA | Months 6, 12, and 24 | Proportion of eyes achieving gains or losses of ≥5, ≥10, and ≥15 ETDRS letters from baseline. |
| Change in Central Retinal Thickness (CRT) | Baseline, Months 6, 12, and 24 | Change from baseline in central retinal thickness measured by optical coherence tomography (OCT). |
| Retinal Fluid Status | Months 6, 12, and 24 (if available) | 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. |
| Number of Intravitreal Aflibercept 8 mg Injections | Up to 24 months | Number of intravitreal aflibercept 8 mg injections administered during follow-up as part of routine clinical practice. |
| Ocular and Systemic Safety | From baseline to Month 24 | Incidence of ocular and systemic adverse events and serious adverse events reported during treatment with intravitreal aflibercept 8 mg under routine clinical practice. |
Contacts
CONTACTCláudia Farinha, MD, PhD
CONTACTAntónio Campos, MD, PhD
Outcome results
None listed