In this issue: In The News Upcoming Events Last Chance Glossary Exploration

	In The News

Increased Risk Of Age-Related Macular Degeneration From Gene Variant

21 Jul 2007

Researchers have found a gene variant that can more than double the risk of developing the degenerative eye disease, age-related macular degeneration.

The macula lies at the centre of the retina and is essential for detailed central vision. Degeneration of the macula interferes with important tasks such as reading and driving.

Age-related macular degeneration (AMD), the cause of which is poorly understood, is the leading cause of visual loss in older people and the commonest cause of blindness in the USA and European countries.

The researchers based their findings on studies of patients with AMD (603 from England and 244 from Scotland) who were compared with 701 unaffected people.

They found that a variant in the complement C3 gene influenced the risk of developing AMD. For the 30% of the population who carry one copy of the so-called 'fast' variant the risk of AMD was increased by 70%, and for the 4% of people with two copies of the 'fast' variant the risk of AMD was more than doubled.

AMD can take two forms called 'wet' (also called choroidal neovascularization or CNV) and 'dry' (also called geographic atrophy or GA). The 'fast' variant in the C3 gene increases the risk of both forms of the disease.

Read the full story here.

Anecortave Acetate Clinical Trial Data for Glaucoma Presented at World Congress of Glaucoma

7/18/2007

Alcon, Inc.  Released today the three-month interim results of the first controlled clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon's space to reduce intraocular pressure in patients with open-angle glaucoma. The data were presented in a poster at the World Glaucoma Congress in Singapore.

In this 12-month proof of concept study, 85 patients were randomly assigned to one of four arms: 3mg, 15mg or 30mg of anecortave acetate or vehicle. Prior to enrolling in the study, all patients had been diagnosed with open-angle glaucoma, had experienced glaucomatous visual field changes and had off-therapy intraocular pressures between 24 mmHg and 36 mmHg. One injection of drug or vehicle was administered to each patient and intraocular pressures were assessed at two weeks, six weeks and at month three. The study will continue with full clinical assessments through the six-month period, with safety follow-up through the conclusion of the study.

The primary conclusion of the poster was that anecortave acetate demonstrated potential for prolonged reduction of intraocular pressure in a significant percentage of patients following a single administration of the drug for all concentrations versus vehicle at month three (ANOVA, p less than 0.05). On a combined basis, 38 percent of patients in the active arms were classified as treatment successes at three months, compared to 24 percent of patients in the vehicle arm. In the highest dose (30mg), 50 percent of patients were defined as treatment successes at three months. On a combined basis, the mean intraocular pressure reduction in the three active arms at three months was 7.2 mmHg, compared to 1.4 mmHg for the vehicle arm (p=0.0014). The poster presented data from the study on an intent to treat basis.

Read the full story here.

Glaucomatous Trabecular Meshworks Show Increased Markers of Calcification

Samples of human trabecular meshwork obtained from deceased glaucoma patients showed significantly increased levels of alkaline phosphatase enzyme activity, a marker of calcification, a laboratory study found.

Terete Borrás, PhD, and colleagues at the University of North Carolina School of Medicine, Chapel Hill, compared levels of calcification markers in trabecular meshwork samples from glaucomatous and normal eyes. They found alkaline phosphatase enzyme activity levels averaged 7.3 ng per µg of DNA for control specimens compared with 37 ng per µg of DNA in glaucomatous tissue samples, according to the study.

Investigators also found that dexamethasone and transforming growth factor beta 2 (TGF?2), which are factors associated with glaucoma, caused a significant up-regulation of alkaline phosphatase activity in two primary cell lines. In addition, glaucomatous tissue showed a –4.4-fold reduction in the expression of the gene that encodes matrix Gla, which inhibits calcification, according to the study.

"The increased activity of the calcification marker, [alkaline phosphatase], in glaucomatous trabecular meshworks might be indicative of an undergoing mineralization process during development of the disease," the authors said. "Inhibition of the calcification mechanism represented by the presence of active [matrix Gla] appears to be compromised in glaucomatous tissue."

The study is published in the July issue of Investigative Ophthalmology & Visual Science.

B&L Withdraws European Marketing Application For Retisert Implant

Bausch & Lomb Ireland has formally notified the European Medicines Agency of its decision to withdraw the application for centralized marketing authorization of B&L's Retisert fluocinolone acetonide 590 µg intravitreal implant, the agency announced in a press release.

The Retisert implant was designated as an orphan medicinal product in March 2005. B&L had submitted a marketing authorization application to the European Medicines Agency (EMEA) in September 2006, seeking approval to market the device as a treatment for chronic, noninfectious posterior segment uveitis.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) was reviewing the application at the time of the withdrawal, according to the release.

In its official letter, B&L stated that it based the withdrawal on the CHMP's request for additional information, which B&L could not respond to within the permitted timeframe, the release said.

Akorn Receives FDA Clearance For Over-The-Counter Topical Ocular Allergy Drug

BUFFALO GROVE, Ill. — Akorn has received U.S. Food and Drug Administration approval to market ketotifen fumarate ophthalmic solution 0.025% for over-the-counter use, Akorn announced in a press release.

The drug is a generic equivalent of Novartis' Zaditor ophthalmic solution 0.025%, which was recently granted over-the-counter status. It is indicated for up to 12 hours of temporary relief for itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Akorn expects to launch the product in October, according to the release.

Bausch & Lomb Likely To Reject AMO Takeover Bid

In a letter issued Tuesday, Bausch & Lomb said it will likely reject Advanced Medical Optics' $75 per share takeover bid unless AMO can provide "credible evidence" that its shareholders will approve the deal.

Senior members of ValueAct Capital, an investment firm owning 14.7% of AMO, voiced strong opposition to the takeover earlier this month.

Responding to Bausch & Lomb's letter, AMO said, "We continue to believe in the strategic and financial rationale for this combination and are confident in our ability to consummate the transaction. We reaffirm our $75 per share offer, which we believe fully and fairly values B&L."

AMO's board will meet Thursday to review the situation. Bausch & Lomb has requested a response by 12:00 p.m. Friday, according to the letter. "We are evaluating B&L's letter and will respond to it in due course," AMO said.

In recent weeks, Bausch & Lomb has been weighing AMO's cash/stock bid against the $65 all-cash bid it has already accepted from private equity firm Warburg Pincus in mid-May.

Bausch & Lomb was hours away from completing a 50-day "go shop" period for courting offers superior to Warburg Pincus' when AMO issued its bid on July 5. AMO was then designated an "excluded party," meaning it could continue negotiating with Bausch & Lomb despite the end of the "go-shop" period.

AMO is the only "excluded party" that has been named, according to Bausch & Lomb, which plans to revoke AMO's status unless AMO can provided evidence of shareholder approval.

Bausch & Lomb declined further comment. AMO could not be reached for comment as of press time.

Heidelberg Engineering Introduces New Perimeter Technology

7/20/2007

Source: Heidelberg Engineering GmbH

Heidelberg Edge Perimeter integrates with the HRT to combine glaucoma structure and function tests.

VISTA, CALIFORNIA and HEIDELBERG, GERMANY– July 13, 2007 – Heidelberg Engineering GmbH will introduce a new perimeter technology at the World Glaucoma Congress being held this week in Singapore. The Heidelberg Edge Perimeter (HEP) uses a unique new stimulus called Flicker Defined Form, which targets M-cells, and has been shown, to be highly sensitive to functional loss due to early glaucoma.

Using flickering black and white patterns, the stimulus creates an illusory edge where the patient perceives a circular stimulus. Not only does this methodology target early glaucoma, it is more comfortable for patients, resulting in higher test-retest reliability than conventional methods.

“The Heidelberg Edge Perimeter is specifically designed to investigate the earliest possible functional damage in patients with glaucoma, whilst also improving on traditional test-retest characteristics in order to better follow disease progression,” noted Professor John Flanagan, University of Toronto, developer of the unique technology.

The Ocular Hypertension Treatment Study highlighted the problems of repeatability frequently associated with standard visual field testing, indicating that 66% of patients returned to ‘normal’ after two consecutive abnormal visual field tests.

In addition to bringing a new approach to visual field testing, the company designed the new device to work in combination with the well-established Heidelberg Retina Tomograph (HRT).

“With a common data platform and new analysis software, the two instruments provide a combined Structure-Function analysis,” according to Dr. Gerhard Zinser, Managing Director and head of Research and Development, Heidelberg Engineering GmbH. “By introducing the true integration of structure and function tests of the optic nerve, we will be providing new insights into the diagnosis and monitoring of the progression of glaucoma.”

“Integration of structural and functional tests of the optic nerve provide exciting potential for enhanced diagnosis and monitoring of progression of glaucoma,” according to Robert N. Weinreb, MD, Distinguished Professor of Ophthalmology and Director of the Hamilton Glaucoma Center at the University of California San Diego at the WGA Consensus on Glaucoma Diagnosis in November of 2003.

“The HEP system is the latest Heidelberg product introduction that incorporates our proprietary TruTrack™ technology,” noted Lisa Underwood, Senior Product Manager, Heidelberg Engineering, Inc. “Together, the HEP and OHTS-proven HRT ensure structure and function information are tracked simultaneously to give the best possible indicators of glaucomatous progression.”

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of instruments for application in retina, glaucoma and cornea diseases. U.S. corporate office is located in Vista, California

	Upcoming Events

Study Coordinator Basic Training

Course Description: This is a comprehensive introduction to Clinical Research for Allied Health Personnel. The foundational preparation required for the role of Clinical Research Coordinator will be provided in a practical unison of the “how-to’s and why’s” which is information that will successfully address the specific tasks you perform as a Study Coordinator. The course manual and other materials helpful to the study coordinator will be provided.

Upon completion of this course, participants will be able to:

• Identify the Roles in the research practice
• Understand why GCP & ICH guidelines are important
• Prepare the regulatory processes
• Conduct binder maintenance & source documentation
• Understand site selection process and set-up
• Identify adverse events and reporting SAE's
• Maintain drug accountability logs
• Prepare for monitoring visits
• Apply the organizational tools provided
• Be able to seek out clinical trials

Aug 16th at our training center in Novi, MI

Registration deadline: Aug 10

SIGN UP NOW!

* * * * * * * * * *

Study Coordinator Intermediate Training

Course Description: This seminar is designed for Study Coordinators with more than 12 months of clinical research experience. Study Coordinator Intermediate Training A-Z takes you beyond Study Coordinator Basic Training A-Z with in depth coverage of protocol evaluations, study budgets, developing a profitable research practice, design standard operating procedures for your site, informed consent process, marketing the clinical research practice and subject recruitment.

Upon completion of the seminar, participants will be able to:

• Evaluate protocols for participation feasibility
• Outline key points that make a budget profitable
• Develop standard operating procedures for your site
• Differentiate the elements that make for a successful research practice
• Write an informed consent that is FDA regulation compliant
• Describe different mediums for marketing clinical research projects
• Identify ways of advertising and increasing subject recruitment

Aug 17th at our training center in Novi, MI

Registration deadline: Aug 10

SIGN UP NOW!

* * * * * * * * * *

The Regulation Binder – Set up & Maintenance Teleclass

Have you ever received regulatory documents and weren’t sure of what to do with them let alone where to put them? Well then this is the class for you!

Learn what to keep, where to keep it and why we keep it.

Once you learn how to set up your Reg Binders, it becomes very easy to put your hands on everything when you need it. You’ll save yourself from a lot of stress and monitors will love your organization!

Course Description: This course is designed to help you prepare the regulatory binder for new and existing protocols, by explaining what actually belongs in the reg binder and what does not. Learn what each document is and why it’s necessary in clinical research. Setting up each of your reg binders in the same format helps save valuable time both for yourself and your monitors.

Learn the ways to improve your organizational skills while setting up your Regulation Binder!

In this 4-week teleclass, you’ll learn:

• What documents should be kept in the Regulation Binder
• The significance of these documents and why we keep them
• What NOT to keep in the Reg Binder
• Tools that will help you keep your documents looking clean and fresh for a long time and free of staple holes.
• How to gauge how many binders you’ll really need for the regulatory documents
• Tips that will help the set up process go smoothly and efficiently        

As a bonus you’ll receive the training manual for continued reference and a set of binder tabs as well!

Can’t make the class? Don’t worry, register anyway and you’ll still receive the training manual, binder tabs and the class recordings so you can learn at your convenience!

Dates: Aug 30, Sept 6, Sept 13, Sept 20

Fee: $159

Click here to register

* * * * * * * * * *

Protocol Evaluations, Budget Analysis & Negotiation Skills Teleclass

Course Description: This teleclass series is designed to improve your evaluation, and negotiation skills. Understanding the overall effect that both the protocol and the budget have on the research practice makes it easier to hone your negotiating skills to maximize on all your efforts. Attention to the small details will often yield the largest rewards. Learn trade secrets that will have your research practice humming in no time!

This teleclass is designed to enable you to step out and start achieving your research goals!

Learn the ways to improve your protocol selection and negotiation skills!

In this 4-week teleclass, you’ll learn:

• Evaluate protocols for participation feasibility.
• Look for the time consumers in the protocol before saying ‘yes’.
• Outline the key points that can make a budget profitable.
• Learn what information must be available to accurately access your budget success.
• Understand the elements of the well-developed protocol and budget.
• Negotiation skills that will pull it all together

Dates: Sept 26, Oct 3, Oct 10, Oct 17

Fee: $159

Click here to register

	Last Chance

Ophthalmic Research Training Services is conducting a survey to help us provide the services you need. Please take a moment and complete our short survey.

Click here to access the survey.

After completing the survey you will receive our Thank You Gift titled: "Research Office and Advertising Tips"

This article is packed with helpful tips that will help you get the most out of your advertising budget. Last chance date to participate in the survey is Aug 15th, please take a few moments and tell us about your needs.

* * * * * * * * * *

If you have not claimed your free E-book "The Acronym & Glossary Guide" please do so today!

To get your free E-book: http://www.ortsedu.com/AGGuide.htm

* * * * * * * * * *

Ophthalmic Research Training Services is continuously looking for ways to improve your expertise and work environment, please visit our newly expanded resource page and see all the ways we’re making getting the information you need even easier! http://www.ortsedu.com/resources.htm

	Glossary Exploration

Each month we’ll help expand your clinical research understanding by exploring the terms and acronyms that we function with everyday. Seems simple right? But, there are so many things that we don’t know and others that we need to know better.

“People do the best with what they know – when they know better they do better!”
- Maya Angelou

INTENTION TO TREAT: A method of analyzing the results of clinical trials. In this analysis, participants are included in the treatment group to which they were originally assigned, even if they eventually received a different treatment. For example, in a trial comparing two doses of a drug, if a participant is assigned to Dose A but actually takes Dose B, that participant is still included with the Dose A group. The intention-to-treat method is the most reliable way to analyze the results of clinical trials.

MEDICAL PRACTICE COMPUTER SYSTEM: A PC- or network-based computer system used to manage electronic patient files. Defined by the European Forum for GCP, such a system is neither sponsor-supplied nor trial specific.

N-of-1 STUDY: A trial in an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment’s effect in that person, often with experimental and control treatments randomized.

OBJECTIVE MEASUREMENT: A measurement that cannot be influenced by investigator bias; for example, blood glucose levels or ECG tracings.

	Special Announcements

Very soon we will have our database completely moved into one central location so that we can provide better service for all our clients. If you’d like to continue to receive information from us please sign up for our newsletter to ensure that you are included in the new database. It’s free and you’ll receive a beneficial list of Tips for a Productive Office as our Thank-You!

Quick Links...