Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degen… (NCT01521819) | Clinical Trial Compass
UnknownNot Applicable
Iray for Vascularized Pigment Epithelial Detachment (VPED) Secondary to Age Related Macular Degeneration
Italy12 participantsStarted 2012-08
Plain-language summary
This is a pilot, single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.
Who can participate
Age range50 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
* Patients with V-PED with serous component comprising greater than 50% of the lesion area, naïve or previously treated with Lucentis® injections and Photodynamic therapy (PDT) using VisudyneÒ.
* Must have a total lesion size of \< 12 disc areas and a 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.
* 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 treatment and follow-up examinations for the 1-year duration of the study.
* Must be at least 50 years of age.
* Women must be post-menopausal ≥ 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, including ocular histoplasmosis syndrome, angioid streaks, multifocal…
What they're measuring
1
Lesion change as measured with fluorescein angiography.