Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

Completed · Phase 4

Conditions studied: Polypoidal Choroidal Vasculopathy

In brief

To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV

Key facts

Study ID

NCT01871376

Run by

Gregg T. Kokame, MD

People needed

25

Starts

2013-05-01

Expected to finish

2016-09-01

Last updated by the study team

2016-11-23

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.