Switching to aflibercept in patients with wet AMD not responding to anti-VEGF treatment.

Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001208-12-NL

Enrollment

Registered

2013-05-17

Start date

2013-08-30

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related macular degeneration

Interventions

Trade Name: Eylea Product Name: Eylea Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients will have received at least 6 anti-VEGF injections within 1 year. - Active neovascular AMD seen as leakage on FA and (sub-) retinal fluid on OCT. - Maximally 1 year since onset of visual complaints and start of anti-VEGF treatment. - Minimally 1 month and maximally 3 months between last anti-VEGF injection and first aflibercept injection. - Age 50 years and older - Visual acuity at baseline between 20/25 and 20/320. - OCT available prior to first injection and after every three anti-VEGF injections. - Give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Signs of subretinal fibrosis, scarring or geographic atrophy on OCT or FA, involving the center of the macula. - Pigment epithelial detachment with a maximum height of =150µm. - Any ocular diseases beside AMD in the study eye, including myopic fundus and vitreoretinal traction. - Myopia of 8.00 D or more, irrespective of myopic fundus features. - Ocular surgery of the study eye = 2 months prior to or during the previous anti-VEGF treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to examine features of treatment response on optical coherence tomography in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment. ;Secondary Objective: To examine change in visual acuity in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment. To evaluate the number of patients responding to aflibercept. To evaluate the number of patients gaining >5 letters of visual acuity from inclusion to study end. ;Primary end point(s): Change in central retinal thickness as measured on OCT between inclusion and one month after 3 monthly aflibercept injections.;Timepoint(s) of evaluation of this end point: At baseline and after 3 months.	—

Measure

Time frame

Main Objective: The objective of this study is to examine features of treatment response on optical coherence tomography in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment. ;Secondary Objective: To examine change in visual acuity in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment. To evaluate the number of patients responding to aflibercept. To evaluate the number of patients gaining >5 letters of visual acuity from inclusion to study end. ;Primary end point(s): Change in central retinal thickness as measured on OCT between inclusion and one month after 3 monthly aflibercept injections.;Timepoint(s) of evaluation of this end point: At baseline and after 3 months.

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Secondary

Measure	Time frame
Secondary end point(s): o Change in visual acuity between inclusion and one month after 3 monthly aflibercept injections. o Number of patients responding to aflibercept defined as a decrease in CRT of >50µm from inclusion compared to visit 5. o Number of patients gaining >5 letters of vision from inclusion compared to visit 5. ;Timepoint(s) of evaluation of this end point: At baseline and after 3 months.	—

Measure

Time frame

Secondary end point(s): o Change in visual acuity between inclusion and one month after 3 monthly aflibercept injections. o Number of patients responding to aflibercept defined as a decrease in CRT of >50µm from inclusion compared to visit 5. o Number of patients gaining >5 letters of vision from inclusion compared to visit 5. ;Timepoint(s) of evaluation of this end point: At baseline and after 3 months.

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Countries

Netherlands

Contacts

Public ContactInvestigator

Radboud University Nijmegen Medical Centre

f.vanasten@ohk.umcn.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026