123 sonography
Dear medical professional!
As an ophthalmologist, you may treat older patients who have geographic atrophy (GA) secondary to age-related macular degeneration (AMD). We wanted to let you know that these older patients may be eligible to participate in the PARASOL research study of an investigational gene therapy.
The primary objective of the PARASOL study is to evaluate the efficacy and safety of a one-time intravitreal injection of the investigational gene therapy when compared to a sham procedure in patients with GA secondary to AMD. This study is sponsored by Janssen Research & Development, LLC.
Eligible patients will:
Be 60 years of age or older
Have non-subfoveal (dehned as not involving the center point of the fovea) GA secondary to AMD with an area measuring 2.5 mm* to 17.5 mm2 (1 and 7 disc areas respectively) in the study eye
Have any pattern of hyper autofluorescence (hyper AF) in the junctional zone of GA in the study eye
Not have a history of or presence of retinal disease other than GA in the study eye
Additional criteria will apply. Total study participation will last about 19 months, which includes study dosing and 18 months of follow-up.
If you have patients who are interested in learning more about this study, they may visit GeographicAtrophyResearch.com for more details. The site includes a pre-screener, which allows them to answer study eligibility questions.
If your patients meet the initial eligibility requirements, they will be prompted to locate the study clinic nearest them and submit their contact information. The site staff will then contact them and set up a screening appointment to determine their study eligibility.
If you would like more information about the PARASOL study or patient referrals, please contact <<contact info>>. If you no longer wish to receive this type of message, please reply to this email.
Please ensure all local policies on patient privacy, including, but not limited to, obtaining written consent as needed, are followed.
Thank you for your consideration of this important research.
Sincerely,
The PARASOL Study Team
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Janssen Research & Development,
LLC 81201887MDG2001-ENG26 INT-3
Version 1.0, 3Aug2023