Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD).

Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD). - BIOIMAGE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002124-17-ES

Enrollment

Unknown

Registered

2013-08-08

Start date

2013-10-04

Completion date

Unknown

Last updated

2017-04-24

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 Product Name: Eylea Product Code: Eylea Pharmaceutical Form: Solution for injection INN or Proposed INN: AFLIBERCET CAS Number: AFLIBERCEPT Other descriptive name: AFLIBERCEPT Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Men and women ? 50 years of age. ? Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. ? ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters. ? Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 124

Exclusion criteria

Exclusion criteria: ? Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD,except dietary supplements or vitamins. ? Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye. ? Prior treatment with anti-VEGF therapy in the study eye is not allowed ? No inflammation / infection in or around the eye ? Known hypersensitivity and allergies. ? Ocular surgery in the past other than cataract surgery. ? No other ocular disease that could lead to decrease of VA.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study genetic variants of VEGF pathway (SNP markers located within the coding and regulatory regions of the genes of the VEGF pathway) and its relation to VEGF trap-Eye treatment efficacy in terms of the percentage of patients with ? 15 letters gain in visual acuity.;Secondary Objective: Overall and genetic subgroups outcomes in: ? Percentage of patients with ?15 letters gain/loss ? Mean change in visual acuity (BCVA)at 52 weeks ? Mean change in OCT central foveal thickness at 52 weeks ? Percentage of patients free of intra or subretinal fluid. ? CNV regression/change at week 52 from Baseline To assess the safety and tolerability of repeated ITV administration of VEGF Trap-Eye in the whole study population.;Primary end point(s): Genetic variants of VEGF pathway (SNPs alleles) and its correlation with percentage of patients with ?15 letters gain at Week 52.;Timepoint(s) of evaluation of this end point: In week 52	—

Measure

Time frame

Main Objective: To study genetic variants of VEGF pathway (SNP markers located within the coding and regulatory regions of the genes of the VEGF pathway) and its relation to VEGF trap-Eye treatment efficacy in terms of the percentage of patients with ? 15 letters gain in visual acuity.;Secondary Objective: Overall and genetic subgroups outcomes in: ? Percentage of patients with ?15 letters gain/loss ? Mean change in visual acuity (BCVA)at 52 weeks ? Mean change in OCT central foveal thickness at 52 weeks ? Percentage of patients free of intra or subretinal fluid. ? CNV regression/change at week 52 from Baseline To assess the safety and tolerability of repeated ITV administration of VEGF Trap-Eye in the whole study population.;Primary end point(s): Genetic variants of VEGF pathway (SNPs alleles) and its correlation with percentage of patients with ?15 letters gain at Week 52.;Timepoint(s) of evaluation of this end point: In week 52

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Secondary

Measure	Time frame
Secondary end point(s): Genetic variants of VEGF pathway (SNPs variants) and its correlation with : ? Mean change in BCVA at week 12 measured by ETDRS Scale ? Percentage of patients with ?15 letters loss in VA ? Percentage of patients with no fluid on OCT at weeks12 and 52. ? Time from first injection until no more fluid is seen on OCT Safety variables: Ongoing safety assessments will include ophthalmic examinations, the recording and evaluation of clinical AEs. Genetic variables: Blood samples will be collected for VEGF pathway genetic variants analysis. Correlations will be studied between the SNPs in the genes of the VEGF pathway and the response to the aflibercept treatment.;Timepoint(s) of evaluation of this end point: Specified above	—

Measure

Time frame

Secondary end point(s): Genetic variants of VEGF pathway (SNPs variants) and its correlation with : ? Mean change in BCVA at week 12 measured by ETDRS Scale ? Percentage of patients with ?15 letters loss in VA ? Percentage of patients with no fluid on OCT at weeks12 and 52. ? Time from first injection until no more fluid is seen on OCT Safety variables: Ongoing safety assessments will include ophthalmic examinations, the recording and evaluation of clinical AEs. Genetic variables: Blood samples will be collected for VEGF pathway genetic variants analysis. Correlations will be studied between the SNPs in the genes of the VEGF pathway and the response to the aflibercept treatment.;Timepoint(s) of evaluation of this end point: Specified above

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Countries

Spain

Contacts

Public ContactElisabet Molina

Trial Form Support

elisabet.molina@tfscro.com+34931850200

Outcome results

None listed

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