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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38763

Enrollment

Registered

2013-05-17

Start date

2013-10-24

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

age-related macular degeneration macular degeneration

Interventions

Patients will be treated with 3 monthly intravitreal injections of 2mg (0,05mL) aflibercept.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with neovascular age-related macular degeneration (AMD) that have shown inadequate response to anti-VEGF treatment, defined as a persistant central retinal thickness on optical coherence tomography (OCT) of >=300 µm combined with a response of no greater than a reduction of 50 µm after each previous intravitreal anti-VEGF treatment.;- Patients will have received at least 6 anti-VEGF injections within 1 year. ;- Active neovascular AMD seen as leakage on fluoresceine angiography 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 (Snellen). ;- OCT available prior to first injection and after every three anti-VEGF injections.;- Give written informed consent.

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 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

Design outcomes

Primary

Measure	Time frame
Change in central retinal thickness (µm) as measured on OCT between inclusion and one month after the 3 monthly aflibercept injections.	—

Secondary

Measure	Time frame
Secondary endpoints are change in visual acuity between inclusion and one month after the 3 monthly aflibercept injections, number of patients responding to aflibercept defined as a decrease in CRT of >50µm from inclusion compared to the last visit and number of patients gaining >5 letters of vision from inclusion compared to the last visit.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)