Navigation Links
Mayo Clinic detective work shows possible side effect in macular degeneration drug
Date:10/24/2011

ROCHESTER, Minn. -- Two major drug trials conclude there was little risk from a drug aimed at age-related macular degeneration. Yet a Mayo Clinic ophthalmologist began to note something concerning in some of her patients: an increase in pressure inside the eye. It led to a retrospective study and findings that will be presented at the American Academy of Ophthalmology in Orlando.

Sophie Bakri, M.D., had been treating patients in her clinic with Food and Drug Administration-approved ranibizumab (Lucentis), when she began noticing a change in some patients.

"I was treating patients and measuring pressures, and I was surprised to see that in some of these people, their intraocular pressure was higher, and they didn't have a diagnosis of glaucoma," Dr. Bakri says. "So, why did the pressure go up? Was it from the drug itself, or the actual injection? Is this real? You don't know if it's a fluke unless you go back and look at the clinical trials. I took a closer look at the pooled data."

Intraocular pressure (IOP) is a measure of fluid pressure inside the eye. Measured in millimeters of mercury (mm/Hg), IOP that is higher than normal or above baseline (higher than 21 mm/Hg) can indicate glaucoma.

Data from the two clinical trials in many ways held the answers to Dr. Bakri's questions, but she found that knowing what to look for helps.

MARINA (Minimally Classic/OccultTrial of the Anti-Vascular Endothelial Growth Factor Antibody Ranibizumab in the Treatment of Neovascular Endothelial Age-Related Macular Degeneration) and ANCHOR (Anti-VEGF antibody for the treatment of predominantly classic Choroidal Neovascularization in Age-Related Macular Degeneration) evaluated drugs including Lucentis, for treatment of age-related and other forms of macular degeneration (AMD). Both were two-year studies with monthly injections of Lucentis, compared to a control group who did not receive the injection. Pooling the two studies, which followed the treatment of 1,125 eyes, Dr. Bakri was able to perform a more robust evaluation of IOP changes. Some patients received Lucentis and others unknowingly received "sham" or mimicked injections, or a laser treatment called verteporfin photodynamic therapy (PDT), which did not involve injection.

Dr. Bakri found what she suspected: a subset of patients had increased IOP.

"We still don't know if it goes up because of the drug or the pressure of the repeated monthly injections, or both," she says. The take-home finding: intraocular pressure should be monitored in eyes receiving ranibizumab.

"A greater proportion of eyes in the ranibizumab groups had IOP increases regardless of the presence or absence of pre-existing risk factors, such as history of glaucoma, suspicion of glaucoma, ocular hypertension or use of a glaucoma medication," Dr. Bakri says.

A small portion, 8 percent, of all eyes across treatment groups received glaucoma medications in the study. Importantly, none of the patients needed glaucoma surgery.

"Our analysis was surprising because the increase was so prevalent and highly statistically significant," Dr. Bakri says. "Lucentis is an excellent drug that works very well, but if we use a drug, we gain long-term experience, and that's where side effects start showing up.


'/>"/>

Contact: Robert Nellis
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
Source:Eurekalert

Related medicine news :

1. Mayo Clinic study: PSA test valuable in predicting biopsy need, low-risk prostate cancer
2. Mayo Clinic study guides physicians using therapeutic cooling to treat cardiac arrest patients
3. Timing for clinical trials for stem cell therapy in spinal cord injuries is right
4. Mayo Clinic wins grant to study ethics of sharing genetic test results with relatives
5. Penn-developed online informed consent tool could boost number of patients in cancer clinical trials
6. Mayo Clinic study: multiple surgeries and anesthesia exposure
7. Cleveland Clinic to establish chair for preventive cardiology from Cleveland Foundation
8. European Journal of Heart Failure publishes new randomized controlled clinical study of RESPeRATE
9. Non-verbal clues guide doctor-patient relationships, clinical judgments, U-M study finds
10. Abiraterone acetate improves fatigue in prostate cancer patients, says international clinical trial
11. TGen-Virginia G. Piper Cancer Center launches clinical trial for drug to treat lung cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... ... , ... Goodcents Deli Fresh Subs today announced the opening of a new ... St. Topeka, Kan. 66604 (near 21st and Gage). It is owned and operated by ... locations in the Topeka and Bonner Springs, Kan. area. , “Goodcents has such ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ensuring meat products have reached ... the importance of correctly using a meat thermometer. The videos feature University of ... on consumer food safety habits. Dr. Bruhn explains the variety of meat thermometers ...
(Date:6/23/2017)... , ... June 23, 2017 , ... 21 Middle East ... (EF) has selected 21 leaders from government, business and civil society in 11 countries ... the U.S. this fall, engaging in a transformative exchange of knowledge and ideas with ...
(Date:6/23/2017)... ... June 23, 2017 , ... PureLife Dental is pleased to announce that California ... members. As part of the amalgam separator endorsement, all CDA members may purchase an ... off the retail value. This partnership between PureLife and CDA is especially timely as ...
(Date:6/23/2017)... ... June 23, 2017 , ... American Farmer, will feature ... which is slated to air fourth quarter 2017. American Farmer airs Tuesdays at 8:30aET ... a Danish pharmacist, founded Chr. Hansen in Denmark in 1874 after a groundbreaking discovery ...
Breaking Medicine News(10 mins):
(Date:6/9/2017)... AirXpanders, Inc. (ASX: AXP) (AirXpanders or Company), ... sale and distribution of the AeroForm® Tissue Expander System, ... commercial roll-out in the United States ... hundred (100) medical institutions and health systems, located throughout ... alternative for women who choose reconstructive surgery following a ...
(Date:6/8/2017)... June 8, 2017   Responding to Heath Ledger,s ... the death of singer Chris Cornell in May, ... International offers a free online psychiatric drug ... and families about psychotropic drug risks. The ... died from an accidental overdose, has called for tighter rules ...
(Date:6/7/2017)... , June 7, 2017  Novavax, Inc., (Nasdaq: ... two Phase 2 trials of its RSV F protein recombinant ... bearing age have been published in the journal ... been shared in prior scientific conferences). The Company previously announced ... 2014. Novavax is developing the RSV F Vaccine with the ...
Breaking Medicine Technology: