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.
Leading the Way in Clinical Research
Our highly skilled and dedicated research team is pleased to announce that we are currently recruiting patients for the following studies.
Regeneron: Designed for diabetic retinopathy patients by using intravitreal injection of a anti-VEGF product. To join the study, patients must
- Have type 1 or type 2 diabetes mellitus
- Be confirmed to have moderately severe to severe nonproliferative diabetic retinopathy
Roche: A Phase 2 study to evaluate an investigational product to treat patients with neovascularization secondary to AMD. To join the study, patients must be
- Treatment-naive with subfoveal or juxtafoveal wet AMD (no prior treatment for CNV) with subfoveal fluid or hemorrhage.
- Best corrected viasual acuity 20/50 to 20/320 (Inclusive) Snellen
For more information, please contact Dr. John Olson or Sherrie Cox:
800.255.7188 // firstname.lastname@example.org
Retina surgeons at the University of Michigan Kellogg Eye Center have performed the first — and second -- surgeries in the United States to implant an artificial retina, or "bionic eye," since the U.S. Food and Drug Administration approved the device last year.
Scientists have discovered a gene that guides the separation of two types of motion-sensing cells, offering insight into how cellular layering develops in the retina, with possible implications for the brain's cerebral cortex. A report on the discovery is published in the Nov. 1 issue of the journal Science.
"The separation of different types of cells into layers is critical to their ability to form the precise sets of connections with each other — the circuitry — that lets us process visual information," says Alex Kolodkin, Ph.D., a professor in the Johns Hopkins University School of Medicine's Solomon H. Snyder Department of Neuroscience and an investigator at the Howard Hughes Medical Institute. "There is still much to learn about how that separation happens during development, but we've identified for the first time proteins that enable two very similar types of cells to segregate into their own distinct neuronal layers."
Kolodkin's research group specializes in studying how circuitry forms among neurons (brain and nerve cells). Past experiments revealed that two types of proteins, called semaphorins and plexins, help guide this process. In the current study, Lu Sun, a graduate student in Kolodkin's laboratory, focused on the genes that carry the blueprint for these proteins in two of the 10 layers of cells in the mammalian retina.
Those two layers are made up of so-called starburst amacrine cells (SACs). One type of SAC, known as "Off," detects motion by sensing decreases in the amount of light hitting the retina, while the other type, "On," detects increases in light. Sun examined the amounts of several semaphorin and plexin proteins being made by each type of cell, and found that only the "On" SACs were making a semaphorin called Sema6A. Sema6A can only work in the retina by interacting with its receptor, a plexin called PlexA2, but Sun found both types of SAC were churning out roughly equal amounts of PlexA2.
Reasoning that Sema6A might be the key difference that enabled the "On" and "Off" SACs to segregate from one another, Kolodkin's team analyzed mice in which the genes for either Sema6A, PlexA2 or both could be switched off, and looked at the effects of this manipulation on their retinas. "Knocking out" either gene during development led the "On" and "Off" layers to run together, the team found, and caused abnormalities in the "On" SACs' tree-like extensions. However, the "Off" SACs, which hadn't been using their Sema6A gene in the first place, still looked and functioned normally.
"When signaling between Sema6A and PlexA2 was lost, not only was layering compromised, but the 'On' SACs lost both their distinctive symmetrical appearance, and, importantly, their motion-detecting ability," Sun says. "This is evidence that the beautiful symmetric shape that gives starburst amacrine cells their name is necessary for their function."
Adds Kolodkin, "We hope that learning how layering occurs in these very specific cell types will help us begin sorting out how connections are made not just in the retina, but also in neurons throughout the nervous system. Layering also occurs in the cerebral cortex, for example, which is responsible for thought and consciousness, and we really want to know how this is organized during neural development."