Clinical Trial for Patients with NPDR
Dear Respected Colleague,
We are pleased to inform you that CFR is participating as a recruiting study site in the Regeneron Pharmaceuticals, Inc. PANORAMA study: a phase 3 study of the efficacy and safety of intravitreal (IVT) aflibercept in patients with moderately severe to severe NPDR.
Approximately 360 patients will be enrolled into the study from approximately 70 sites in the US. The study will last 100 weeks (2 years) and eligible patients will be randomly assigned to 1 of 3 treatment groups:
- IVT aflibercept dosing regimen 1
- IVT aflibercept dosing regimen 2
- Sham (fake injection)
We are looking for men or women ≥ 18 years of age with:
- Type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) (corresponding to a Diabetic Retinopathy Severity Score [DRSS] of level 47 or 53, confirmed by the central reading center), in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months.
BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
Who have no:
- Presence of DME threatening the center of the macula in the study eye
- Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA)
- Prior focal or grid laser photocoagulation or any prior PRP in the study eye
- Prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
- Prior intraocular steroid injection in the study eye
- Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
As with all carefully regulated clinical research studies, the health of your patients will remain our utmost priority at all times. At the end of the study, your patients will be referred back to you along with a written summary of their study-related care.
I would be grateful if you could discuss this opportunity with your patients, as appropriate, and ask them to contact our study team if they would like to learn more about this study. If you have any questions, or would like to refer a patient, please contact 800.255.7188 or my study coordinator Sherrie Cox at email@example.com. Thank you for your time and consideration. We hope to hear from you soon.
John C. Olson, M.D.