Overview

This trial is active, not recruiting.

Condition neovascular macular degeneration
Treatments aflibercept (eylea, vegf trap-eye, bay86-5321), visudyne
Phase phase 4
Target VEGF
Sponsor Bayer
Collaborator Regeneron Pharmaceuticals
Start date May 2014
End date August 2016
Trial size 333 participants
Trial identifier NCT02120950, 16995, 2013-004464-54

Summary

To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients receive Eylea 2mg plus SHAM PDT as indicated
aflibercept (eylea, vegf trap-eye, bay86-5321)
Eylea is administered as an intravitreal injection
(Experimental)
Patients receive Eylea 2mg plus ACTIVE PDT as indicated
aflibercept (eylea, vegf trap-eye, bay86-5321)
Eylea is administered as an intravitreal injection
visudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Primary Outcomes

Measure
Change of ETDRS BCVA (Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity)
time frame: From baseline to 52 weeks

Secondary Outcomes

Measure
Number of participants of with a loss of less than 15-letter on BCVA scale
time frame: From baseline to week52

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Signed informed consent - Men and women ≥50 years of age - Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center Exclusion Criteria: - Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry - Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry - Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT) - History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green. - History of allergy to aflibercept, verteporfin, or their excipients.

Additional Information

Official title A Randomized, Double-masked, Sham-controlled Phase 3b/4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy as Indicated in Subjects With Polypoidal Choroidal Vasculopathy
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.