Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME

NCT07761039 | Not Yet Recruiting

• 1 other identifier: GER-001/2026
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

nAMD; DME

Keywords

Neovascular age-related macular degeneration; Diabetic macular oedema; Aflibercept 8 mg; Interval extension; Real-world evidence; Treat-and-extend

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, Months 6, 12, and 24 (if available)

• Change in BCVA

  Months 6, 12, and 24

• Change in Central Retinal Thickness (CRT)

  Baseline, Months 6, 12, and 24

• Retinal Fluid Status

  Months 6, 12, and 24 (if available)

• Number of Intravitreal Aflibercept 8 mg Injections

  Up to 24 months

Study Arms (2)

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

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.

Drug: Aflibercept 8mg

Interventions

Aflibercept 8mg DRUG

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.

DME Cohort; nAMD Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.

Sponsors & Collaborators

• Grupo de Estudos da Retina: lead

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Cláudia Farinha, MD, PhD

CONTACT

+351965635880; claudia.farinha@hotmail.com

António Campos, MD, PhD

CONTACT

acamposoft@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share