Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 25 - 95 |
Updated: | 10/11/2017 |
Start Date: | November 2010 |
End Date: | August 2014 |
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively
This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal
choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 25 years
- Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active
leakage, active bleeding or recent decrease in vision
- BCVA using ETDRS of 20/32 to 20/400
Exclusion Criteria:
- Any history of previous vitrectomy
- Any prior treatment with verteporfin photodynamic therapy in the study eye.
- Previous cataract surgery within the preceding 2 months of Day 0
- Active intraocular inflammation in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either
eye
- A condition that, in the opinion of the investigator, would preclude participation in
the study (e.g., unstable medical status including blood pressure, cardiovascular
disease)
- 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.
- Prior anti-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in
the study eye prior within 30 days prior to enrollment in this study
- Known allergy to any component of the study drug
- Blood pressure >180/110 (systolic above 180 or diastolic above 110) If blood pressure
if brought below 180/110 by anti-hypertensive treatment, the patient can become
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 infraction, 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.
- History of recurrent significant infections or bacterial infections
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered
effective means of contraception, surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in conjunction
with spermicide gel, an intra uterine device (IUD), or contraceptive hormone implant
or patch
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial.
We found this trial at
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