Status:
COMPLETED
Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation
Lead Sponsor:
Gregg T. Kokame, MD
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
25+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01871376
Start Date
May 1 2013
End Date
September 1 2016
Last Update
November 23 2016
Active Locations (1)
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1
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States, 96701