Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exuda… (NCT01871376) | Clinical Trial Compass
CompletedPhase 4
Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation
United States25 participantsStarted 2013-05
Plain-language summary
To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV
Who can participate
Age range25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-hypertensi…
What they're measuring
1
efficacy of intravitreal aflibercept injection of 2.0mg aflibercept