Aflibercept treatment in age-related macular degeneration

Predictability of response of aflibercept treatment for wet age-related macular degeneration under the treat-and-moderate extend regimen (TMER) treatment model

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001394-41-FI

Enrollment

Registered

2015-04-15

Start date

2015-06-10

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Wet age-related macular degeneration

Interventions

Trade Name: Eylea Pharmaceutical Form: Injection Other descriptive name: AFLIBERCEPT Concentration unit: 1X 100 milligrams/millilitre Concentration type: equal Concentration number: 40mg/ml-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 50-85 years, BCVA 0.0625-0.8 Snellen 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: -no background diabetic/proliferative retinopathy -no previous arterial/venous occlusions of the eye -no previous retinal tears/detachments -no previous fundus laser coagulation -no previous retinal necrosis -no previous optic nerve inflammation -no previous vitreous haemorrhages -no previous vitreitis/endophthalmitis -no ocular/periocular infection -no glaucoma -no pathologic myopia -no eye surgeries in the previous six months -no hydrocephalus/intracranial pressure that increases intracranial expansion -no immunologic systemic disease -no use of other anti-neoplastic drugs -no pulmonary embolism, myocardial or cerebral infarction in the previous six months -no clinically significant cardiovascular disease (unstable angina pectoris, TIA) -no pregnancy or breast feeding -no renal failure -no hypothyroidism (or, if present, under therapeutic control) -no alcohol abuse -no previous gastrointestinal perforations -no hypersensitivity to an active agent (aflibercept)

Design outcomes

Primary

Measure	Time frame
Main Objective: Optimization of TER protocol;Secondary Objective: Not applicable;Primary end point(s): the mean change from the baseline best corrected visual acuity and the number of injections over the 24 months;Timepoint(s) of evaluation of this end point: 24 months	—

Secondary

Measure	Time frame
Secondary end point(s): the length of time achieved in treatment intervals (treatment frequency), the number/frequency of relapses, changes retinal thickness. ;Timepoint(s) of evaluation of this end point: 24 months	—

Countries

Finland

Contacts

Public ContactClinical Trials Information

Raimo Tuuminen

raimo.tuuminen@helsinki.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 14, 2026