Polypoidal Choroidal Vasculopathy
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).
Detailed description
To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.
Interventions
Sponsors
European Vision Institute Clinical Research Network
Association for Innovation and Biomedical Research on Light and Image
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Either gender and Age ≥ 50. * Naïve PCV patients. * Confirmed diagnosis of symptomatic macular PCV in the study eye. * Greatest linear dimension of the lesion of \< 5400 mm, assessed by ICG angiography. * BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25). * Lesion size in the study eye at study entry: * Presence of PCV assessed by the Central Reading Centre based on ICG with active polyps with or without abnormal vascular network. * Women must be using effective contraception, be post-menopausal for at least * months prior to trial entry, or surgically sterile. * Ability to provide written informed consent. * Ability to return for all study visits.
Exclusion criteria
* Active inflammation or infection in the study eye. * Uncontrolled intraocular pressure in the study eye. * Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema). * Presence of centromacular scarring or atrophy indicating irreversible BCVA loss. * Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry. * Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | from Baseline (Week 0) to Week 52. | Unit of Measure: \[Letters\] |
| Polyps regression | from Baseline (W0) to Week 52. | Unit of Measure: \[Yes, No\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of leakage based on fluorescein angiography (FA) | from Baseline (W0) to Week 52 | Unit of Measure: \[Yes, No\] |
| Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT); | from Baseline (W0) to Week 52 | Unit of Measure: \[µm\] |
| Polyps regression, assessed by Indocyanine Green Angiography (ICGA); | from Baseline (W0) to Week 16 | Unit of Measure: \[Yes, No\] |
| Total number of treatments with Aflibercept; | from Baseline (W0) to Week 52 | Unit of Measure: \[#\] |
| Frequency and severity of ocular and non-ocular adverse events over time. | from Baseline (W0) to Week 52 | Unit of Measure: \[Mild, Moderate, Severe\] |
| Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52; | from Baseline (W0) to Week 52 | Unit of Measure: \[Yes, No\] |
| Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA); | from Baseline (W0) to Week 52 | Unit of Measure: \[Yes, No\] |
Countries
Portugal, Spain
Outcome results
None listed