IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degenerati⦠(NCT01516294) | Clinical Trial Compass
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IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD
Italy12 participantsStarted 2012-01
Plain-language summary
This study will evaluate the efficacy of IRay treatment in patients with Polypoidal Choroidal Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion of lesion activity and lesion size at 12 months.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Patients with PCV, naĆÆve or previously treated with Lucentis injections and Photodynamic therapy (PDT) using Visudyne.
* Must have a total lesion size of \<12 disc areas and a PCV lesion with the greatest linear dimension of \<6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter (determined by ICG).
* The distance from the center of the fovea to the nearest edge of the optic disc should be not less than 3 mm. (This distance is confirmed by Oraya software prior to treatment.).
* Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
* Must be willing and able to return for scheduled visits for the 2-year duration of the study.
* Must be at least 50 years of age.
* Women must be post-menopausal ā„1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study.
* Must have best corrected visual acuity of 75 to 25 letters (inclusive) in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).
Exclusion Criteria:
* CNV due to causes other than AMD or PCV, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivaleā¦
What they're measuring
1
Lesion change as measured with fluorescein angiography.