A separately published paper on the same study reported that vitamin D intake was associated with a decreased rate of early AMD, but only in women less than 75 years old.

The studies drew participants from the Carotenoids in Age-Related Eye Disease Study, an offshoot study of the Women’s Health Initiative Observational Study.

For abstracts of the recent articles in Archives of Ophthalmology, click here and here.

Risa Schulman, PhD
Expert, Healthy Food and Dietary Supplement Science, Marketing and Regulatory
Tap~Root

Identifying what are known as the “binding proteins” behind the uptake of lutein and zeaxanthin into the human macula helps researchers better understand the role of these carotenoids in eye health and disease.

The binding protein in the human retina has been found for zeaxanthin, but until now not for lutein.  Moving from prior research in silkworms and primates, researchers at the University of Utah have identified StARD3 as a human retinal lutein-binding protein.  This development will help researchers further explore the role of such proteins in retinal physiology and disease.

For the study abstract, click here.

Risa Schulman, PhD
Expert, Healthy Food and Dietary Supplement Science, Marketing and Regulatory
Tap~Root

A multi-center trial will involve twelve patients. If the results are positive, Advanced Cell Technology anticipates filing for an IND to treat age-related macular degeneration, as well as filing to begin clinical trials in Europe in the very near future.

For all of the details, follow this link.

Illuvien is a new hope in the treatment of diabetic macular edema (DME). Illuvien delivers fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years, thus forgoing the need for multiple drug injections and/or laser treatments to alleviate the symptoms.

Well, Alimera, the company behind Illuvien, received good news yesterday in the form of notification from the FDA that its NDA (new drug application) for Iluvien had been accepted for filing and granted Priority Review status. FDA Priority Review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 months to six months.

With priority review, Alimera could receive a response from the FDA in the fourth quarter regarding its NDA for Iluvien, which was submitted at the end of June 2010.

This is exciting news for patients, and will provide an alternative to laser, frequent injections and off-label treatments currently available for DME.

Here is a link to the full article.

For the complete story (and how it compares to NeoVista’s Epi-Rad 90 system), please take a look.

NeoVista, Inc. announced the completion of enrollment in its global 450-patient randomized controlled study of their revolutionary epimacular brachytherapy procedure for the treatment of neovascular age-related macular degeneration (AMD). The Company will now begin the mandated one-year data follow-up before submitting the final clinical module of its Pre-Market Approval (PMA) submission to the FDA.

“It’s exciting to reach this long anticipated milestone in the CABERNET Study,” said John N. Hendrick, President and CEO of NeoVista. “Neovascular AMD affects hundreds of thousands of patients globally. It is our hope that upon one-year follow-up, the data will support FDA approval in a most timely manner so that retinal surgeons, patients, and heath care systems in the US and around the world will have a cost effective option available for treating this dreadful disease in the immediate future.”

The largest study of its kind to date, the multi-center CABERNET (CNV Secondary AMD Treated with BEta RadiatioN Epiretinal Therapy) Study assigned patients into one of two arms: a control arm where patients were administered regular Lucentis® injections and a one time surgical arm, where patients were administered a dose of strontium-90 beta radiation via a short surgical procedure, followed by concomitant injections of Lucentis when needed. The primary efficacy endpoint for the CABERNET Study is based on one-year follow-up of the surgical arm cohort when compared to the control group.

“The CABERNET Study has brought together multi-disciplinary clinical teams aligned around the mission of addressing the serious problem of neovascular AMD,” said Pravin U Dugel, Managing Partner, Retinal Consultants of Arizona, Phoenix, Arizona and principal investigator for the CABERNET Study. “I look forward to the final results of this ambitious clinical trial. More than any other recent trial, this clinical trial has the potential of improving the quality of life and the overall treatment of patients with neovascular AMD. It could potentially have a significant impact on the practice patterns and economics of retinal physicians as well as global health care systems.”

Source: Company News Release

The abstract reports that:

Mean follow-up was 10.69±5.95 months (range: 3 to 16 months). Mean preoperative spherical equivalent refraction (SE) was –3.03±3.23 diopters (D) and defocus was 4.67±3.29 D; at last follow-up SE and defocus were statistically significantly reduced to –1.29±2.05 D and 3.04±2.53 D, respectively (P<.01). Preoperative mean (logMAR) uncorrected visual acuity was 0.99±0.81 and best spectacle-corrected visual acuity was 0.21±0.19, which improved postoperatively to 0.16±0.15 and 0.11±0.15, respectively. The mean steepest keratometry was reduced from 48.20±3.40 D preoperatively to 45.13±1.80 D at last follow-up. 

Based on these results, researchers concluded that “[s]imultaneous PRK followed by CXL seems to be a promising treatment capable of offering functional vision in patients with keratoconus.”

For access to the abstract and full text of the article, go here (subscription required for full text).

The study by the BU School of Medicine and the VA Boston is not part of the CATT Study, but is a randomized double-blind study of the two drugs for treating AMD. According to the abstract and the news release, there was no difference in effectiveness after six months.

Source: Science Codex

Here’s the link to the writeup in my online Journal

A project funded by the MBF Foundation is showing that blood vessels in the retina can be photographed and the images analysed by a computer to accurately determine a person’s risk of heart attack or stroke – cardiovascular diseases that change the appearance of blood vessels in the eye.

Lead CERA researcher, Professor Tien Wong, said they aim to show that combining this non-invasive retinal scan with the results from current risk assessment methods will improve precision and reliability in predicting cardiovascular disease.

Source: Medical News Today

For the latest about the French study, please see my Avastin/Lucentis Update 25.

I expect that, although the CATT Study one-year results probably will not be released until next Spring, some initial thoughts might be heard at the upcoming AAO Meeting in San Francisco. If so, I hope to report on those thoughts in this space following the meeting.

Source: APM Health Europe