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Dr. Ronald Frenkel helps new drug get FDA approved for patients to recover their eyesight!
A new drug has just been FDA approved to treat patients with blockages of blood vessels in their eyes.
Ronald Frenkel, MD, FACS, FICS served as the Principal Investigator for the studies at the Eye Research
Foundation and East Florida Eye Institute in Stuart, for the first clinical trials regarding the safety and
effectiveness of Lucentis for the treatment of Retinal Vein Occlusion (RVO). The use of Lucentis is now FDA
approved to treat this condition, for which no drug treatment had previously been available. Our patients
were fortunate to receive the drug about two years prior to it being available to the general public, at no
cost.
As part of a national multi-center trial, two different clinical studies were performed at the Institute. The
BRAVO study assessed Lucentis in a total of 397 patients with reduced vision from macular swelling following blockages of branches of retinal veins. The CRUISE study assessed Lucentis in a total of 392
patients with reduced vision due to macular swelling following blockages of the main vein that returns blood
to the heart from the eye. Patients treated with Lucentis in both studies significantly improved their vision.
This is the first time that a drug has been shown to help these patient recover their vision.
1. Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG,
Murahashi WY; CRUISE Investigators (including Frenkel, REP). Ranibizumab for
macular edema following branch retinal vein occlusion: six-month primary end point
results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.
Click the link to read the whole article:
http://www.ophsource.org/periodicals/ophtha/search/quick
2. Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY,
Rubio RG; BRAVO Investigators (including Frenkel, REP). Ranibizumab for macular
edema following branch retinal vein occlusion: six-month primary end point results
of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1.
Dr. Frenkel Co-Authors Chapter in, The Glaucoma Book, on the Changes and Developments in Monitoring Fluid Pressure in the Eye.
Glaucoma, the leading cause of blindness in the United States, is a disease of the optic nerve caused by increased fluid pressure in the eye. The only known and widely accepted treatment for glaucoma is the lowering of the fluid pressure, through the use of medications or surgery. Each medication used to treat glaucoma is unique, with different peak times of lowering pressure. Doctors typically measure the efficacy of the medications during office work hours, three or four times a year. The problem is that “these measurements provide only a snapshot of a parameter that is known to change significantly over hours, minutes, and even seconds….These isolated measurements...do not provide a complete picture of the state of the patient.”
The current methods of measuring eye fluid pressure limit the ability of doctors to treat glaucoma. For doctors to properly treat patients: it is essential for them to have devices that will not only accurately measure fluid eye pressure, but that will do so overtime.
Through accurate measures, multiple factors can be documented and analyzed, including: a patients’ baseline fluid pressure and fluctuations. In having comprehensive data spanning overtime, the relationship between multiple factors, including: blood pressure, pulse and eye fluid pressure, can be studied in depth. The benefits of continuously measuring fluid eye pressure will result in the ability of doctors to better guide treatment.
Attempts at creating devices that continuously measures fluid pressure are still under development, but it is certain that the technique must be able to take measurements quickly enough to capture the dynamic behavior. Although home tonometers have been designed (including a self-use model), they present several drawbacks that include: the possibility for complications to the cornea, patients unwillingness to constantly repeat measurements, and potential for inaccuracy.
Currently, there are various implantable monitoring devices under development. A wireless sensor has been created that can be implanted into the iris of the eye. Contact lenses are being developed that can detect changes in the curve of the eye within the cornea due to increased pressure. We are currently working on an implantable device that transmits data to an external probe and stores information for up to 30 days. The data can be electronically transferred to a physicians office through the use of a phone line or internet.
“There is no doubt that when we have such a device it will fundamentally change our understanding of IOP [fluid pressure], and the diagnosis and treatment of glaucoma.”
1. Frenkel, R.E.P., Haji, S., Frenkel, MPC. Continuous Monitoring of Intraocular Pressure. The Glaucoma Book, in Press Springer, New York, NY, 2010. In, Schacknow, PN and Samples, JR (Editors), The Glaucoma Book, NY, NY, Springer Scientific, pp.59-64, 2010
Reproducibility of a New Optic Nerve and Sectoral Neuroretinal Rim Damage Assessment Scale in Patients with Glaucoma
Through an optic nerve assessment, a retrospective view was carried out on 14 randomly chose charts of glaucoma patients (who met certain criteria) to determine the reproducibility of a new optic nerve and sectoral neuroretianl rim damage assessment. Due to hurricane damage, the patient charts were not available to examiners. Thus this masked assessment was done without any previous records or tests beings avaible to the examiner. After the charts become available (post-hurricane damage restoration) the masked optic nerve assessments were compared to the prior assessments. A scale from 1-4 was used to measure the rim thinning of the superotemporal (ST), temporal (T), and inferotemporal (IT) rims. The scale utilizes indirect slit-lamp ophthalmoscopy with either a 60D or 66D lens, in patients with glaucoma.
The results showed that sectoral neuroretinal rim damage in patients with glaucoma can be assessed in a very reproducible manner.
R. E. Frenkel, S. A. Haji, and M. Frenkel
Reproducibility of a New Optic Nerve and Sectoral Neuroretinal Rim Damage Assessment Scale in Patients with Glaucoma
Invest. Ophthalmol. Vis. Sci. 51: E-Abstract 2719.
Patients- and Physician- Reported Satisfaction Following Treatment with Bimatoprost 0.01% or Vehicle in Patients with Glaucoma or Ocular Hypertension (OHT)
In a double-masked, multicenter, parallel-group study of 222 patients, the patient- and physician-reported outcomes of treatment were analyzed. The study focused on the efficacy and safety of bimatoprost 0.01% in the treatment of patients with glaucoma or OHT (whose intraocular pressure was adequately controlled with latanoprost). Through a series of questions, both patients and physicians assessed to their satisfaction following treatments. Patients answered questions regarding: eye appearance and their willingness to continue treatment. Physicians answered questions regarding their willingness to continue use of the medication.
After a month of treatment, a significant difference was observed in the responses. Change in eye appearance was reported by 5% of the patients (7) in the bimatoprost arm and by 6% of patients (4) in the vehicle arm.
Patient- and Physician-Reported Satisfaction Following Treatment With Bimatoprost 0.01% or Vehicle in Patients With Glaucoma or Ocular Hypertension (OHT)
Invest. Ophthalmol. Vis. Sci. 51: E-Abstract 170.
Although it is difficult to find patients who develop acute IOP rises to measure the effect on blood flow, the recent advent of IVT injections provides an opportunity to understand this effect. Patients, receiving these injections of anti-VEGF drugs, are known to typically develop significant IOP spikes. This allows us to investigate the effects of these spikes on retinal capillary blood flow.
The retinal blood flow on eight patients, four of whom had glaucoma, was measured immediately before and one minute after an IVT injection of ranibizumab, through the use of a scanning laser Doppler flowmetry. The retinal capillary blood flow was measured at the supertemporal and inferotemporal retina adjacent to the optic nerve, including the superotemporal and inferotemporal optic nerve rim.
There was a negative correlation between the rise in IOP after the IVT injection and the change in retinal capillary blood. In all of the patients, the retinal blood flow decreased after the IVT injection, with a mean of 29%. Our results suggest that there is an immediate decrease in retinal capillary blood flow in patients who develop IOP spikes after an IVT injection of ranbizumab.
M. P. Frenkel, S. A. Haji, and R. Frenkel
The Effect of Acute IOP Rise on Retinal Capillary Blood Flow
Invest. Ophthalmol. Vis. Sci. 51: E-Abstract 5123.
A retrospective chart review was done on 40 patients to determine if IOP spikes vary in patients with phakic vs pseudophakic eyes after intravitreal injuction of anti-VEGF drugs. All the patients received a single IVT injection of one of two anti-VEGF drugs, either .05 ml of ranibizumab or .05ml of bevacizumab, for exudative AMD. The IOP were measured one minute after the IVT injection.
There was a statistically significant difference in mean IOP at 1 min between the phakic vs pseudopkhakic eyes. In the phakic group, there was a slight positive correlation between the total cataract score and the IOP spike. Our results suggest that the patients with phakic eye are at a higher risk of developing an IOP at one minute compared to pseudophakic eyes after intravitreal injection of an anti-VEGF drug.
S. A. Haji, M. M. P. Frenkel, and R. E. Frenkel
Phakic Eyes Have a Higher Risk of Developing Immediate IOP Spikes After Intravitreal (IVT) Injection of Anti-VEGF Drugs
Invest. Ophthalmol. Vis. Sci. 51: E-Abstract 5124.