Polypoidal Choroidal Vasculopathy
Conditions
Keywords
PCV
Brief summary
To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV
Detailed description
This is an open-label, randomized, one-year, multiple-dose study of 2mg aflibercept in patients with PCV. The study consists of the baseline visit on day 0 and a mandatory clinic visit every 30 days to assess efficacy and safety. All patients will receive three monthly injections of 2mg intravitreal aflibercept injection followed by treatment every 60 days through 720 days (24 months). Patients can be treated every 30 days if needed. The fellow eye may be treated with intravitreal aflibercept injection per the investigator's discretion at any point during the study if evidence of disease activity are met: exudation or hemorrhage secondary to polypoidal choroidal vasculopathy or exudative AMD. The fellow eye will not be considered the study eye. If treatment with aflibercept is to be given in the fellow eye, the injections are to be administered according to the Food and Drug Administration (FDA) approved label for EYLEA®.
Interventions
DRUGIntravitreal aflibercept injection 2.0mg
Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms.
Sponsors
Regeneron Pharmaceuticals
Gregg T. Kokame, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 25 years of age. * In the opinion of the principal investigator, the study eye has PCV with active exudation and/or bleeding that may benefit from treatment with study medication. * Diagnosis of PCV via ICG Angiography with evidence of active leakage, active bleeding or recent decreased in vision. * Baseline visual acuity better than or equal to 20/200 using ETDRS * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent
Exclusion criteria
* Any history of previous vitrectomy * Previous cataract surgery within the preceding 2 months of Day 0 * Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * Presence of any condition that would jeopardize the patient's participation in this study * Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry * For the Treatment-Naïve cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis, Eylea) in the study eye * For the Previous-Treated cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days or enrollment in this study * For the Previous-Treated cohort: no prior Eylea in the study eye * Known allergy to any component of the study drug * Blood pressure \>180/119 (systolic above 180 or diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the patient can be eligible. * Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter * Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization * Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization * Pregnant or breast-feeding women * Simultaneous participation in another medical investigational trial * Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of intravitreal aflibercept injection of 2.0mg aflibercept | 2 Years | This study will evaluate the efficacy of intravitreal aflibercept injection of 2.0mg aflibercept administered Q8W following an initial loading dose of 3 monthly injections in patients with polypoidal choroidal vasculopathy with active exudation or bleeding as measured by: • Mean change in BCVA between Day 0 (Baseline) and Day 720 (M24) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients with decrease in Subretinal Hemorrhage and/or Exudates | Month 6, Month 12, Month 18, Month 24 | To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18), Day 720 (M24) in decreasing subretinal hemorrhage and/or subretinal exudates via fundus photos and fundus exams |
| Proportion of patients with decreased / complete resolution of Polypoidal Polyp. | Month 3, Month 6, Month 12, Month 18, Month 24 | To evaluate the proportion of subjects with a decrease and/or complete resolution of polypoidal polyps from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) as assessed by fluorescein and indocyanine green angiography |
| Proportion of subject with a decrease or complete resolution of branching vascular network from PCV | Month 3, Month 6, Month 12, Month 18, Month 24 | To identify the proportion of subjects with a decrease and/or complete resolution of branching vascular network (BVN) from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) months as assessed by fluorescein and indocyanine green angiography |
| Determine mean change in Central Foveal Thickness and/or peripapillary edema as measured by SD-OCT | Baseline, Month 6, Month 12, Month 18, Month 24 | To determine mean change in central foveal thickness (CFT) and/or peripapillary edema as measured by spectral domain optical coherence tomography (SD-OCT) in central and/or paracentral fields from Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) |
| Proportion of Patients with Stable, Improved, Significant Improved, Decreased, Significant Decreased Vision | 6 Months, 12 Months, 18 Months, 24 Months | To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) with Stable vision \<5 letters gained or lost, Improved vision \>5 letters gained, Significant Improved vision ≥15 letters gained, Decreased vision \>5 letters lost, Significant Decreased vision ≥15 letters lost |
| Proportion of previously treated and treatment naive patients that require additional dosing outside of the protocol determined dosing schedule | Month 24 | To identify proportion of patients between previously treated and treatment naïve patients that require additional dosing outside of the protocol determined dosing schedule: 3- initial monthly dosing followed by dosing every other month for 720 days (M24) |
| Assess changes on Autofluorescence | Baseline, Month 6, Month 12, Month 18, Month 24 | To assess changes on autofluorescence (AF) as seen on images from Day 1 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) |
| Incidence and Severity of Ocular and Non-Ocular Adverse Events | Baseline through Month 24 | To determine the incidence and severity of ocular and non-ocular adverse events from Day 1(Baseline) through the end of the study (Day 720) |
| Mean Change in Choroidal Thickness | Baseline, Month 6, Month 12, Month 18, Month 24 | To determine mean change in choroidal thickness (at fovea) as imaged via EDI-OCT between Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18), and Day 720 (M24) |
Countries
United States
Outcome results
None listed