Navigation Links
Clinical trial for diabetic macular edema enrolling patients
Date:3/26/2010

NEW YORK, March 26, 2010 A Phase II clinical trial for a promising treatment for diabetic eye disease has begun enrolling participants.

The Juvenile Diabetes Research Foundation, a leader in setting the agenda for diabetes research worldwide, and The Wilmer Eye Institute of Johns Hopkins University announced today that the READ 3 Study (Ranibizumab for Edema of the mAcula in Diabetes Protocol 3 with High Dose Study) will evaluate the safety and efficacy of a injections of an antibody treatment in people with diabetic macular edema (DME).

DME is a major complication of diabetes and a leading cause of blindness in adults. In DME, leakage of fluid from the blood vessels in the eye causes the retina to swell, resulting in blurring and visual loss.

The READ-3 Study is a collaboration between JDRF and Johns Hopkins University, with funding support from Genentech, Inc. (a member of the Roche group), and involves 14 clinical centers across the U.S. that will collectively enroll some 100 patients. The Wilmer Eye Institute of Johns Hopkins University will serve as the Coordinating Center for the participating clinical sites, and the Retinal Imaging Research and Reading Center at Wilmer will serve as the Reading Center for the READ 3 Study.

READ-3 is a Phase 2 study designed to compare two different doses of the antibody treatment to determine if a higher dose is more effective in improving vision and decreasing retinal thickness; it will also determine if higher doses can reduce the frequency of subsequent treatments for DME.

After screening to confirm diabetic macular edema (and no other factors that would exclude someone from the study), the participants will receive either 1 or 2 doses of ranibizumab for six months, followed by a six-month follow up-period with the option for additional treatments. Participants must be at least 18 years of age and have macular edema as the result of diabetes. For additional study information and participation, please visit www.READ3.net or JDRF's Clinical Trials Connection at www.trials.jdrf.org.

Without treatment, diabetic macular edema can cause vision impairment, blurriness, or blindness. Therapies to free people from the devastating health burden of complications that can accompany diabetes, including diseases of the eye, nerves, and kidneys, are an important focus of JDRF research; in the last fiscal year, the foundation invested more than $22 million in research involving Complications Therapies.

About Ranibizumab and the READ Studies

The READ-3 Trial is the third READ study to test the effectiveness of ranibizumab as a treatment of diabetic eye disease.

Ranibizumab is an antibody designed to block a protein called vascular endothelial growth factor (VEGF), which is produced in excessive amounts in people with diabetes. VEGF causes leakage in the small blood vessels of the eye that can lead to vision loss and, eventually, blindness. In the READ-1 study, Dr. Quan Dong Nguyen, Dr. Peter Campochiaro, and colleagues at the Wilmer Eye Institute of Johns Hopkins University (under the JDRF collaboration) treated 10 patients who suffered from chronic diabetic macular edema. The trial participants received injections of the drug, with follow-up injections at one, two, four, and six months. The injections were well-tolerated and the results showed that ranibizumab significantly reduced macular swelling and improved vision.

In the READ-2 Study (a multi-center national trial also supported by JDRF) designed by Dr. Nguyen, Dr. Campochiaro, and Dr. Diana Do of the Wilmer Eye Institute, researchers from 14 clinical centers throughout the U.S. enrolled 126 patients to compared the effectiveness of ranibizumab versus conventional treatment laser photocoagulation therapy. The study results showed a significantly greater improvement in vision in patients treated with ranibizumab than those receiving laser surgery or a combination of both.

Dr. Nguyen, Dr. Campochiaro, Dr. Do, and 14 other clinician scientists from clinical centers in California, Florida, Hawaii, Illinois, Kansas, Maryland, Pennsylvania, South Dakota, and Texas designed the READ-3 Study.

Ranibizumab was approved by the U.S. Food and Drug Administration for the treatment of patients with a type of age-related macular degeneration in June 2006. In addition to the READ studies, Genentech is conducting two parallel, phase 3 trials studying the safety and efficacy of different doses of ranibizumab to treat diabetic macular edema.


'/>"/>

Contact: Joana Casas
mcasas@jdrf.org
212-479-7560
Juvenile Diabetes Research Foundation International
Source:Eurekalert

Related biology news :

1. Singapore program to provide clinical insight; showcase for regional research
2. AADR awards 2010 Neal W. Chilton Fellowship in Clinical Research to Dolphus Dawson, III
3. Cell-enriched fat grafts improve long term graft retention in preclinical study
4. GenWay Clinical Laboratory receives accreditation from College of American Pathologists
5. UAB bone center director wins distinguished service award from clinical pathology society
6. TNO and Seventh Wave sign letter of intent on joint preclinical pharmaceutical outsourcing services
7. Magnetic nanotags spot cancer in mice earlier than methods now in clinical use
8. RadMD reaches 150th clinical trial
9. New cancer drug test promises safer and more effective clinical trials
10. IRSF announces funding of first clinical trial with disease-modifying therapy for Rett syndrome
11. General tumor marker test now offered by GenWay clinical laboratory
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/15/2016)... , April 15, 2016 ... the,  "Global Gait Biometrics Market 2016-2020,"  report to ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The global gait biometrics ... of 13.98% during the period 2016-2020. ... angles, which can be used to compute factors ...
(Date:4/13/2016)... 13, 2016  IMPOWER physicians supporting Medicaid patients in ... new clinical standard in telehealth thanks to a new ... higi platform, IMPOWER patients can routinely track key health ... mass index, and, when they opt in, share them ... to a local retail location at no cost. By ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys has ... CEO, Barrett Bready , M.D., who returned to ... the original technical leadership team, including Chief Technology Officer, ... Product Development, Steve Nurnberg and Vice President of Software ... the company. Dr. Bready served as CEO ...
Breaking Biology News(10 mins):
(Date:5/26/2016)... Despite the volatility that continues to envelop the ... research on ActiveWallSt.com directs the investor community,s focus on the ... ), Cerus Corp. (NASDAQ: CERS ), Arrowhead Pharmaceuticals ... Inc. (NASDAQ: FPRX ). Register with us today ... On Wednesday, shares in Massachusetts ...
(Date:5/26/2016)... Diego, CA (PRWEB) , ... May 26, 2016 ... ... development and manufacturing company, today announced several positive developments that position the Company ... As a result of the transaction, Craig F. Kinghorn has been appointed Chairman ...
(Date:5/25/2016)... ... May 25, 2016 , ... Lajollacooks4u has become a rising ... been rated one of its top attractions. Fortune 500 companies, such as Illumina, ... a unique and intimate team-building experience. , Each event kicks off with an olive ...
(Date:5/25/2016)... ... May 25, 2016 , ... ... of fracture-specific plating options designed to address fractures of the distal tibia and ... , The Acumed Ankle Plating System 3 is composed of seven plate families ...
Breaking Biology Technology: