Polypoidal Choroidal Vasculopathy MedDRA version: 20.1 Level: PT Classification code 10063381 Term: Polypoidal choroidal vasculopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Eylea 40mg/ml solution for injection in a vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 8621
Sponsors
AIBILI - Association for Innovation and Biomedical Research ob Light and Image
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Either gender and Age = 50. 2. Naïve PCV patients. 3. BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25). 4. Diagnosis of symptomatic macular PCV in the study eye. Subfoveal involvement is required, with intraretinal or subretinal fluid and/or subfoveal PED, demonstrated on SD-OCT. (confirmed by the Central Reading Centre based OCT, CFP, FA and ICGA). 5. Greatest linear dimension of the lesion of = 5400 µm, assessed by FA/ICGA angiography. 6. Presence of PCV in the study eye assessed by the Central Reading Centre based on ICGA with active polyps with or without abnormal vascular network. 7. Women must be post-menopausal for at least 12 months prior to trial entry, or surgically sterile or in case of child-bearing potential, women must be using highly effective method of birth control (i.e. one that results in a failure rate less than 1% per year when used consistently and correctly, such as, combined hormonal contraception, progestogen-only hormonal contraception, intrauterine devices (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence). 8. Ability to provide written informed consent. 9. Ability to return for all study visits. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Active inflammation, infection or periocular infection in the study eye. 2. Uncontrolled intraocular pressure in the study eye. 3. 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). 4. Presence of centromacular scarring or atrophy indicating irreversible BCVA loss. 5. Prior treatment of the study eye with anti-VEGF therapy. 6. Systemic use of anti-VEGF products within 3 months prior to the study entry. 7. Previous vitrectomy, aphakia, macular laser treatment, PDT, or intraocular steroids in the study eye. 8. Known serious allergies or history of hypersensitivity to fluorescein, indocyanine, verteporfin or components used of Eyelea® formulation. 9. Subject with a condition (such as advanced, severe or unstable disease or its treatment) or is in a situation which may put him/her at significant risk, which may confound the study results or may interfere significantly with the subject’s participation in the study. 10. History of porphyria and clinically relevant impairment of liver function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1- Change in BCVA from Baseline to Week 52 (1-year). 2- Polyps regression at Week 52, assessed by ICGA. ; Timepoint(s) of evaluation of this end point: 1- Change in BCVA from Baseline to Week 52 (1-year). 2- Polyps regression at Week 52, assessed by ICGA. ; Main Objective: To evaluate the efficacy of Aflibercept with and without PDT in AMD patients diagnosed with PCV, by: 1- Comparing best corrected visual acuity (BCVA) changes at Week 52 in AMD patients with PCV treated with Aflibercept associated with verteporfin PDT versus BCVA in AMD patients with PCV treated with Aflibercept associated with sham PDT. 2- Comparing polyps regression at Week 52 in AMD patients with PCV treated with Aflibercept associated with verteporfin PDT versus polyps regression in AMD patients with PCV treated with Aflibercept associated with sham PDT. Polyps regression will be defined as a reduction in the total area of polyps, as assessed by the Central Reading Centre. ; Secondary Objective: To evaluate the potential benefit, based on the secondary outcomes, of verteporfin PDT compared to sham PDT in AMD patients diagnosed with PCV treated with Aflibercept under a Treat and Extent treatment regimen. To evaluate the safety of Aflibercept treatment in patients with PCV. To characterize morphologically the 2 treatment regimens: Aflibercept T&E associated with verteporfin PDT and Aflibercept T&E associated with sham PDT. To identify potential genetic biomarkers of PCV. To identify genetic biomarkers of PCV that may influence treatment response; to identify genetic differences between PCV patients of Caucasian; and Asian populations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Change in BCVA over time; 2- Change in BCVA at Week 16; 3- BCVA gain = 5, 10, or 15 Letters at Week 52; 4- BCVA loss = 5, 10, 15, or 30 Letters at Week 52; 5- BCVA Maintenance at Week 52 (BCVA change from Baseline between - 5 and + 5 Letters, exclusively); 6- Polyps regression at Week 16, assessed by ICGA; 7- Complete polyps regression at Week 52, assessed by ICGA; 8- Complete polyps regression at Week 16, assessed by ICGA; 9- Presence of active polyps at Week 52, assessed by ICGA; 10- Presence of active polyps at Week 16, assessed by ICGA; 11- Presence of leakage based on fluorescein angiography (FA) at Week 52; 12- Change in the Subfield Central Retinal Thickness (CRT) over time (assessed by Optical Coherence Tomography, SD-OCT); 13- Presence of fluid assessed on SD-OCT at Week 52; 14- Total number of treatments with Aflibercept; 15- Total number of treatments with verteporfin PDT; 16- Frequency and severity of ocular and non-ocular adverse events over time. 17- Pre-identified single-nucleotide polymorphisms (SNPs). ; Timepoint(s) of evaluation of this end point: 1,2- Change in BCVA at week 16 and over time 3,4- BCVA gain/loss = 5, 10, or 15 Letters at Week 52 5- BCVA Maintenance at Week 52 6- Polyps regression at Week 16 7,8- Complete polyps regression at Week 16 and Week 52 9,10- Presence of active polyps at Week 16 and Week 52 11- Presence of leakage at Week 52 12- Change in the Subfield Central Retinal Thickness over time 13- Presence of fluid at Week 52 14- Total number of treatments with Aflibercept at Week | — |
Countries
Portugal, Spain
Contacts
Public ContactSónia Simões
AIBILI - Association for Innovation and Biomedical Research ob Light and Image
Outcome results
None listed