Overview

This trial is active, not recruiting.

Condition wet macular degeneration
Treatment aflibercept (eylea, vegf trap-eye, bay86-5321)
Phase phase 4
Sponsor Bayer
Collaborator Regeneron Pharmaceuticals
Start date December 2014
End date December 2016
Trial size 255 participants
Trial identifier NCT02305238, 17668

Summary

To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) .

To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Aflibercept is intravitreally injected for 96 weeks. The treatment interval of injection is adjusted by two weeks according to the criteria.
aflibercept (eylea, vegf trap-eye, bay86-5321)
Aflibercept 2mg is intravitreally injected.
(Experimental)
Aflibercept is intravitreally injected for 96 weeks. The treatment interval of injection is adjusted by four weeks according to the criteria.
aflibercept (eylea, vegf trap-eye, bay86-5321)
Aflibercept 2mg is intravitreally injected.

Primary Outcomes

Measure
Mean change from baseline in best-corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 52
time frame: Baseline and Week 52

Secondary Outcomes

Measure
Proportion of subjects who maintain vision at Week 52
time frame: Baseline and Week 52
Proportion of subjects who gain at least 15 letters of vision compared to baseline at Week 52
time frame: Baseline and Week 52
Mean change in Central Retinal Thickness (CRT) from baseline at Week 52
time frame: Baseline and Week 52
Proportion of subjects without fluid on Optical coherence tomography (OCT) at Week 52
time frame: Week 52
Number of participants with adverse events as a measure of safety and tolerability
time frame: up to 2 years

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Japanese men and women ≥ 50 years of age - Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD, including juxta-foveal lesions that affect the fovea as evidenced by fluorescein angiography (FA) in the study eye - Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study eye Exclusion Criteria: - Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser, intraocular corticosteroids, surgical interventions (except cataract surgery more than 30 days prior to screening) or systemic use of anti-VEGF products within 3 months prior to study entry - Active or suspected infection in or surrounding of the study eye - Active severe intraocular inflammation in the study eye - Intraocular pressure (IOP) ≥ 25 mmHg in the study eye - Ocular condition in the study eye which may impact vision and confound study outcomes

Additional Information

Official title A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.