RECENT PUBLICATIONS
Dr. Frenkel’s research was published in the British Journal of Ophthalmology.
Using a simple gray filter to stress patients’ eyes, ophthalmologists are able to predict visual acuity change during anti-vascular endothelial growth factor A (anti-VEGF) therapy for wet age-related macular degeneration (AMD), according to a new study.
“Now we are able to tell patients with a high degree of accuracy how they will do with anti-VEGF injections,” Dr. Ronald E.P. Frenkel, who led the study, told Reuters Health by phone. “The method is so elegant and it has incredible predictability. We couldn’t tell patients before what to expect.”
He noted that previously, the test had proved helpful in patients with dry AMD, but this is the first time anyone has tested it in patients with wet AMD.
Dr. Frenkel, of Bascom Palmer Eye Institute, Miami, and colleagues conducted the HARBOR trial, a two-year, phase 3 randomized trial of intravitreal ranibizumab (Lucentis) 0.5 or 2.0 mg monthly or as needed in wet AMD patients. A total of 1,084 patients were enrolled in the trial. Their mean age was 78.7 years and about 60 percent were women. In a Nov. 5 online paper in the British Journal of Ophthalmology, Dr. Frenkel and colleagues report change in best corrected visual acuity (BCVA) under optimal illumination over the course of the two-year study. The researchers also evaluated low-luminance visual acuity (LLVA).
Click here to view the Abstract in the British Journal of Ophthalmology.
Dr. Frenkel discovers a way to predict prognosis for Wet Macular Degeneration patients.
Ronald Frenkel, MD, FACS, FICS has discovered a new way to let patients with Wet Macular Degeneration know the prognosis of treatment before they start it. Dr. Frenkel has been awarded this presentation at the annual meeting of ARVO, the Association for Research in Vision and Ophthlalmology, the largest eye research meeting in the world. Dr. Frenkel served as Principal Investigator at the East Florida Eye Institute in Stuart. He headed up the portion of the colossal national multi-center HARBOR clinical trial for Wet Macular.
Degeneration treatment that discovered how to predict the patient’s prognosis and response to treatment, when one is first diagnosed with the disease. The study had 99 participating centers from across the United States and enrolled 1097 patients with newly diagnosed Wet Macular Degeneration. This will have a significant impact on patients and their families as such a prognosis does not currently exist.
Avoiding blood pressure dips helps prevent worsening of glaucoma
Current risk factors for glaucoma include high eye pressure, age, family history, and thin corneas. Through our research, we have discovered a new risk factor for glaucoma: nighttime dips in blood pressure. By having patients wear a blood pressure monitor for a 24-hour period, we have found that patients with worsening glaucoma despite “controlled” eye pressures have significant drops in their blood pressure at night. Decreased blood pressure causes decreased blood flow to the optic nerve, resulting in glaucomatous nerve damage. We work with patients’ medical doctors to diminish this risk so that glaucoma can be prevented or stabilized. (Presented at the Annual Meeting of the American Academy of Ophthalmology)
New combination treatment can improve vision in patients with certain retinal problems
Patients who have vision loss secondary to a lack of oxygen to the eye may get an improvement in vision from high tension oxygen treatment, given in association with laser and steroid therapy. This was demonstrated in a patient who had vision loss from radiation treatment for a brain tumor, who regained his vision after combination treatment. (Presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology)
Glaucoma medication can be administered differently to decrease eye redness & improve comfort
We are currently investigating methods to reduce side effects from glaucoma drops, allowing more patients to benefit from these drugs. Patients who have been unable to tolerate the latest, most effective pressure lowering drugs often have had success with this new method that alters the dosing of the drug. (Submitted for presentation)
Eye pressure spikes which occur at night and during sleep are important to control
Doctors have long known that when a patient’s eye pressure is checked in the office it is just a sampling of the routine fluctuations that everyone has over a 24 hour period. Although eye pressure may appear controlled in the office, by measuring it around the clock, we have found that eye pressure not only increases during sleep, but also increases when patients are lying down versus when they are sitting up. This is a concern for glaucoma patients and suspects. By monitoring patients treated with different medications, we are determining which drugs are better able to treat this problem.
CLINICAL RESEARCH DEPARTMENT
The many research projects currently underway for Macular Degeneration, Diabetic Eye Disease, Glaucoma, and Dry Eye Disease rapidly impact EFEI patients’ treatments and outcomes. The doctors at our vision research center in Stuart have witnessed the difference these advances can make for patients, and they strive to apply the knowledge they gain through their research to the needs of our patients every day. By combining state-of-the-art diagnostic equipment with the latest clinical advances, our patients receive cutting edge treatments, which are customized to their individual situations.
OUR RESEARCH IS RECOGNIZED ALL AROUND THE WORLD.
The contributions of the Doctors at EFEI to the treatment of Wet Macular Degeneration and Glaucoma have been featured in the leading European Ophthalmology Journal—Euro Times, on the Macular Degeneration website: Med Page Today, MD Support , as well as on the internationally recognized medical research website Doctor’s Guide , where research was ranked as a key contribution of the year. In addition, the EFEI doctors have taught their findings to doctors from around the world at the annual meetings of the Association for Research in Vision and Ophthalmology, the American Academy of Ophthalmology, and the Asia-Pacific Academy of Ophthalmology.
CLINICAL TRIALS
IF YOU HAVE ANY QUESTIONS ABOUT CLINICAL RESEARCH AT EAST FLORIDA EYE INSTITUTE, OR ARE INTERESTED IN PARTICIPATING IN A CLINICAL TRIAL, PLEASE CONTACT US USING THIS FORM
YOU MAY ALSO SUBMIT YOUR CONTACT INFORMATION AND DIAGNOSIS IF YOU WOULD LIKE TO BE CONTACTED FOR A FUTURE CLINICAL TRIAL.
• DIABETIC MACULAR EDEMA
• WET MACULAR DEGENERATION TREATMENT NAÏVE
• WET MACULAR DEGENERATION WITH PRIOR TREATMENT
• GEOGRAPHIC ATROPHY SECONDARY TO MACULAR DEGENERATION
• OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Allergan 1833-201-407
Protocol Title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in
Participants with Open-Angle Glaucoma or Ocular Hypertension
AGN-193408 SR in the treatment of open-angle glaucoma or ocular hypertension
Apellis
APL2-GA-305 PEGCETACOPLAN (APL-2)
A Phase 3, Open-Label, Multicenter, Extension Study to Assess Safety and Efficacy of Pegcetacoplan in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
IONIS GOLDEN | IONIS PHARMACEUTICALS, INC.
ISIS 696844-CS5
A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Iveric ISEE2008
A Phase 3, Randomized, Placebo-Controlled, Double-Masked, Sham controlled Clinical Trial to Assess Safety and Efficacy of, INTRAVITREAL ADMINISTRATION OF ZIMURA™
(COMPLEMENT C5 INHIBITOR) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
PROTOCOL NO: ISEE2008
GATHER2
OPTHEA
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the
Efficacy and Safety of Intravitreal OPT-302 in Combination with
Aflibercept, Compared with Aflibercept Alone, in Participants with
Neovascular Age-related Macular Degeneration (nAMD)
Protocol Number:
OPT-302-1005
Regeneron
VGFTe HD DME 1934
Randomized, Double-Masked, Active-Controlled Phase 2/3 Study
to Assess Safety and Efficacy of Multiple Doses of AFLIBERCEPT in patients with Diabetic Macular Edema.
SANDOZ
Protocol CSOK583A12301
A 52-week Multicenter, Randomized, Double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea®, administered intravitreally, in patients with neovascular age-related Macular Degeneration
Special thanks to those who have participated in our studies.
For our valued patients that have recently participated in our clinical studies, thank you so much for helping us with recent approvals of:
• EYLEA FOR WET MACULAR DEGENERATION AND CRVO
• BEOVU FOR WET MACULAR DEGENERATION
• LUCENTIS FOR DIABETIC MACULAR EDEMA
• OZURDEX FOR DIABETIC MACULAR EDEMA
• UPNEEQ FOR DROOPY EYELID
• DUREZOL FOR USE AFTER OCULAR SURGERY
• OMIDRIA FOR CATARACT SURGERY
• DURYSTA FOR GLAUCOMA
• ZIOPTAN FOR GLAUCOMA
• SIMBRINZA FOR GLAUCOMA
• TRAVATAN Z FOR GLAUCOMA