Polypoidal Choroidal Vasculopathy (PCV) MedDRA version: 16.1 Level: PT Classification code 10063381 Term: Polypoidal choroidal vasculopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Eylea
Product Name: Aflibercept
Product Code: not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
Other descriptive name: AFLIBERCEPT
Concentration
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to read and understand the ICF (or, if unable to read due to visual impairment, to be read to verbatim by the person administering the informed consent or a family member). 2. Signed informed consent. 3. Men and women =50 years of age. 4. Diagnosis of symptomatic macular PCV in the study eye established by ICGA at the study center 5. Greatest linear dimension of the lesion of =65 years) yes F.1.3.1 Number of subjects for this age range 155
Exclusion criteria
Exclusion criteria: 1. Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry. 2. Any prior use of intraocular anti-VEGF agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry 3. Prior macular laser treatment in the study eye including PDT. 4. Only one functional eye (a functional eye is defined as one that is not legally blind) even if that eye is otherwise eligible for the study. Furthermore, subjects with only one eligible eye should not have other ocular conditions with poorer prognosis in the fellow eye. 5. Any ocular disorders in the study eye that, in the opinion of the investigator, may confound interpretation of study results or interfere with subject safety. 6. Concomitant systemic disease which may affect the subject´s regular visits or contraindicate use of PDT. 7. Participation in an investigational study within 30 days prior to the initial screening visit that involved treatment with any drug (excluding vitamins and minerals) or device. 8. Pregnancy or lactation. 9. History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green. 10. History of allergy to aflibercept, verteporfin, or their excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is the mean change in BCVA from baseline to Week 52.;Timepoint(s) of evaluation of this end point: Week 52.;Main Objective: To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy rescue treatment in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration. To explore whether intravitreally administered aflibercept monotherapy is non-inferior to that of aflibercept plus photodynamic therapy (as indicated) based upon best-corrected visual acuity in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of age-related macular degeneration.;Secondary Objective: To estimate the proportion of subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration who require rescue therapy To estimate whether or not and to what extent rescue therapy is beneficial in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration who have suboptimal responses to aflibercept monotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoint is avoidance of at least a 15-letter loss at Week 52 (“maintenance of visual acuity”) from baseline to Week 52.;Timepoint(s) of evaluation of this end point: Week 52. | — |
Countries
Australia, Germany, Hong Kong, Hungary, Japan, Korea, Republic of, Singapore, Taiwan
Contacts
Public ContactCTP Team / Ref: "EU CTR" / S102 - R
Bayer HealthCare AG
Outcome results
None listed