The study involves patients that have undergone PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

Click here for further details.

Briefly, a frequent manifestation of diabetic retinopathy (DR) is diabetic macular edema (DME) for which the only proven treatment is laser photocoagulation. In the retina, microglia are capable of migrating through the retina to sites of inflammation to associate closely with neurons and the vasculature, and are key cellular players in the processes of chronic inflammation implicated in DME. For these reasons, microglia represent a promising cellular target for forms of therapy that limit the inflammatory changes found in DR.

The objective of the trial is to investigate the safety and efficacy of dextromethorphan as a microglia inhibitor to help prevent the inflammation and swelling present in DME. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema.

Click here for further details about the trial and participation eligibility.

The drug delivery system is triggered by an external magnetic field. The team accomplished this by sealing the reservoir of the implantable device with an elastic magnetic polydimethylsiloxane (silicone) membrane. A magnetic field causes the membrane to deform and discharge a specific amount of the drug, much like squeezing water out of a flexible bottle.

Click here to read the full release.

As the recipient of the award, Dr. Efron discussed his work developing the technique he described as “rapid, painless, non-invasive, sensitive, reiterative, cost-effective, and clinically accessible.”  It is based on assessing corneal nerve structure and function using corneal confocal microscopy and non-contact corneal esthesiometry, and retinal nerve structure and function using optical coherence tomography and perimetry.  Using these tools, it has been shown that morphological damage to the nerves in the cornea is associated with the nerve damage in the extremities that can result from poorly controlled diabetes (called diabetic peripheral nephropathy).

The testing could be done as part of a routine eye check. While the techniques still need further validation, they pave the way for a role for the optometrist in the management of diabetes.

For a press release about the lecture, click here.

For an abstract of a paper written by Dr. Efron on the topic, click here.

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

Probably the biggest news from this year’s ARVO Meeting was the presentation of results of the one-year results of the CATT Study, along with its publication in the NEJM.

Previously, I summarized the results from the NEJM that showed equivalency of Avastin and Lucentis, but with the latter having a 40x larger price tag.

During the presentation at ARVO, the study co-authors presented on some of the preliminary safety data that they had collected, but not yet published. This was, perhaps, to refute the charges made by Genentech later in the week that a retrospective study that they had had conducted by a researcher from Johns Hopkins showed that Lucentis was apparently safer than Avastin (surprise!). In the data presented by Drs. Martin and McGovern, there were no major differences in safety. See my writeup:

CATT Update 15: Preliminary Two-Year Safety Data Presented at ARVO

Alimera presented on a subset of their FAME Study using Iluvien to treat DME. In this study, the subset data showed that 34% of patients treated with the low dosage of Iluvien that had had DME for three or more years before treatment, gained three lines of vision after therapy.

This subset of data will be provided to the FDA in response to the CRL letter issued by the FDA in December 2010, in response to the New Drug Application filed last summer.

See: Iluvien Update 2: New Safety and Efficacy Data Presented at ARVO

I have been closely following the exciting news about the Ellex 2RT laser treatment for stopping the progression of dry AMD. Based on the 12-month data presented at ARVO, it appears that we may have a non-invasive treatment that might be able to stop dry AMD in its tracks and prevent the progression into the vision-losing forms of this disease.

See: Ellex 2RT Updated Clinical Results: ARVO 2011

Authors of a recent study questioned whether annual eye exams were the most cost-effective way of screening for eye conditions in this population, and compared it with two treatment alternatives: telemedicine and exams every two years instead of every year.  Telemedicine involves exams using voice or visual interaction with a doctor who is in a different location than the patient.

By examining the literature and existing surveys, the researchers showed that either telemedicine or check ups every two years was more cost-effective than an annual exam.  They commented that seeing the doctor for the full exam annually added little benefit in detecting diabetic retinopathy.

Diabetes affects an estimated 10 million people between the ages of 30-84.

For an abstract of the article, click here.

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

In GALILEO, the primary endpoint at week 24 was achieved: 60.2 percent of patients receiving monthly VEGF Trap-Eye 2 milligrams (mg) gained at least 15 letters of vision from baseline, compared to 22.1 percent of patients receiving sham injections (p<0.0001). The key secondary endpoint of the study was also met: patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001).

Regeneron stated that with two Phase 3 trials now showing impressive improvement in vision relative to control, VEGF Trap-Eye has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion.

Click here for the full release.