MyVisionTest Newsletter Archive
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In January 2004, Florida lawmakers passed legislation requiring all drivers age 80 years and older to pass a vision test before renewing their driver's license.
In the October 2008 edition of Archives of Ophthalmology, researchers report that between 2001 and 2006 highway deaths in Florida among drivers age 80 and older fell by 17% while the overall number of highway fatalities rose by 6%.
It is not entirely clear why the death toll for older drivers fell during the study period, but similar declines have occurred in other States that have implemented mandatory vision screening requirements for older drivers.
While it is tempting to speculate that the new law removed visually impaired drivers from the road, there is no evidence to suggest that happened. The data show that 93% of older drivers were able to pass the vision test and renew their license, suggesting only a small number of visually impaired drivers were removed from the roads.
Another possibility is that the vision screening requirement lead people with poor vision to obtain an eye exam before renewing their license. Undergoing cataract surgery, or simply obtaining a new pair of eyeglasses, could enable a driver to pass the vision test who might otherwise have failed.
Vision screening laws save lives. We would like to see them in all 50 States.
A study of polypoidal choroidal vasculopathy (PCV) treated with photodynamic therapy (PDT) finds that early gains in visual acuity following the procedure are lost within 2 years.
PCV is characterized by an abnormal network of polyp-like blood vessels within the choroid. The polypoidal lesion often produces exudative detachment of the overlying retinal pigment epithelium and retina. PDT is considered a safe and effective treatment for PCV. In most studies, the polypoidal lesion disappears after PDT, and visual acuity (VA) improves. However, there is no information on the long-term results of this treatment.
The current study involved a retrospective analysis of 41 eyes of 38 patients with PCV that were followed for at least 24 months.
Average visual acuity (VA) improved at 12 months after the procedure, but then declined significantly at 24 months. At the 12-month follow-up examination, only 7 of 41 eyes had worse VA than when the procedure was performed. However, this number increased to 13 of 41 eyes at 24 months, and had reached 17 of 41 eyes at the final follow-up visit. At the final examination, the average VA of patients with bilateral PCV (but not unilateral PCV) was significantly worse than when PDT was originally performed.
The researchers were unable to identify the reason for the VA decline. They state that they failed to detect any progressive changes after stabilization of the PCV lesion.
The investigators conclude that PDT does not result in successful long-term treatment of PCV, especially in patients with bilateral disease.
WHAT IT MEANS TO YOU: This is the second 2-year follow-up study of PDT published recently to demonstrate that early gains in visual acuity are followed by a decline in the second year. The other study involved patients with AMD rather than PCV, but the trend towards worsening VA in the second year is very similar to what was found in this report. Attempts to improve outcomes following PDT have included decreasing laser energy (low fluence), decreasing the dosage of verteporfin, and shortening the time period between drug infusion and laser application. Time will tell whether these changes are able to improve the long-term visual outcome following PDT.
Analysis of data from a large epidemiologic study provides information about the rate and pattern of progression of geographic atrophy (GA), the end-stage of dry AMD.
A private census of the population of Beaver Dam, Wisconsin, was performed. Examinations were performed on all willing residents at baseline, and then every 5 years thereafter. Ninety-five persons with GA were identified. Thirty-two persons were seen at multiple visits with GA in the same eye to evaluate changes in lesion size.
GA lesions were classified into three configurations based on the number of atrophic areas and appearance of the atrophy. The first was classic and referred to a single, usually round, area of GA. The second, multifocal, indicated two or more separate areas of GA. The third, merged, indicated multifocal lesions that had grown together into one or more larger irregular lesions, often with satellite areas of atrophy projecting off of the main circular lesion.
At the examination when GA was first identified (n=95), 45% had a classic single GA lesion, 18% had multifocal GA lesions, and 37% had a merged GA lesion.
Eyes with multifocal GA were most likely to have the area of atrophy increase (mean: 12 sq mm), to have atrophy progress to the foveal center (83%), and to have a decrease in vision (mean: 22 letters).
Eyes with a classic single GA lesion were least likely to have the area of atrophy increase (mean: 2 sq mm), to have the lesion progress to the foveal center (22%), and to have a decrease in vision (mean: 10 letters).
No systemic factors, such as hypertension or smoking status, were associated with progression of the atrophy.
WHAT IT MEANS TO YOU: Understanding the natural history of the disease is crucial in evaluating the effectiveness of potential treatments. The slow nature of dry AMD makes studying its progression more challenging than the more rapid changes that occur in wet AMD. The population-based nature of this study suggests the findings are more likely to reflect the true natural history of this disease than previous studies, which are based upon findings in patients that visit the office of retinal specialists.
A comprehensive review of the scientific literature by the American Academy of Ophthalmology (AAO) finds that anti-VEGF therapy is a safe and effective treatment for neovascular AMD. There is high quality evidence to support this conclusion for Macugen (pegaptanib) and Lucentis (ranibizumab), but none for Avastin (bevacizumab) at this time.
The literature review suggests that anti-VEGF pharmacotherapy, delivered by intravitreal injection, is a safe and effective treatment for neovascular AMD, for up to 2 years of follow-up for Macugen and for up to 1 year of follow-up for Lucentis. There is level I evidence to support this conclusion for Macugen and Lucentis.
Level I research is well-designed and well-conducted randomized clinical trials. Level II research includes well-designed case-control and cohort studies and poor-quality randomized studies. Level III research includes case series, case reports, and poor-quality cohort and case-control studies.
The data suggest that vision outcomes with Lucentis are superior to those with Macugen, and there is no definitive evidence to suggest a difference in safety between the drugs. As a result, Macugen is not a commonly used therapy for neovascular AMD.
There is level II and level III evidence that suggests Avastin, delivered by intravitreal injection, may be a safe and effective treatment for neovascular AMD, but the possibility that vision outcomes and safety may be inferior to those for Lucentis has not been ruled out.
WHAT IT MEANS TO YOU: This endorsement by the AAO establishes anti-VEGF therapy with Lucentis and Macugen as the "Gold Standard" for the treatment of neovascular AMD. By acknowledging that the vision outcomes for Macugen are inferior to those for Lucentis, and that there is no clear safety advantage for Macugen, the AAO has clearly given the nod to Lucentis as the current standard of care for this disease. This however, may change as new studies emerge, such as the much anticipated head-to-head comparison between Avastin and Lucentis in the Comparison of AMD Treatments Trials (CATT).
Investigators report good results 24-month after a telescopic magnifying device is surgically implanted into one eye of a series of patients with bilateral end-stage AMD.
The Implantable Miniature Telescope prosthesis is a compound telescope system that is designed for monocular implantation in phakic eyes with poor central vision.
In the multi-center Implantable Miniature Telescope 2 (IMT002) clinical trial, 206 patients received the telescope prosthesis implant. One-year outcomes were reported in 2006, and showed that 67% of eyes with the implant achieved a 3-line or greater improvement in best-corrected distance visual acuity (BCDVA) compared with 13% of fellow eyes. Endothelial cell density (ECD) was reduced by 25% at 1 year.
At two years, data from 174 of 188 available patients were analyzed, or 84.5% of the original 206 implanted patients. Specifically, of the 206 patients implanted with the telescope prosthesis, 10 (5%) of 206 were deceased, eight (4%) of 206 had the device removed (two device failures, two cases of corneal edema, and four patient requests), 13 (6%) of 206 were lost to follow-up, and one (0.5%) of 206 missed the two-year visit. Of the 4 patients who requested device removal, 3 of these patients reported glare in bright light, and the other patient reported a reduction in peripheral vision and depth perception.
Overall, 60% of 173 telescope-implanted eyes gained three lines or more of BCDVA compared with 10% of fellow control eyes. Mean ECD stabilized through two years, with 2.4% mean cell loss occurring from one to two years.
The investigators conclude that the two-year results reflect the continued benefit of the device for this patient population.
WHAT IT MEANS TO YOU: Advances in ocular surgery have made possible a number of very sophisticated implantable low vision devices. However, the merits of these devices is still unclear. As any low vision specialist will tell you, there is no such thing as a "cure all" low vision device. Most aids are tailored to a specific task. Therefore, it is not unusual to see a variety of devices being prescribed, each designed to meet a particular need. Add to that the question of how a person adapts to having a permanently magnified image in one eye. Mobility and hand-eye tasks will have to be relearned. Risk of falls and injury are a real possibility. Finally, there is the question of long-term intraocular safety and stability of such a device. That said, this research is very exciting and offers real hope of someday achieving a higher level of visual functioning than may be achievable with conventional low vision aids.
A new study reports good success treating acute central serous chorioretinopathy (CSCR) with a safety-enhanced photodynamic therapy (PDT) protocol.
CSCR is characterized by the accumulation of subretinal fluid in the macula, and is a common condition in young adults. Research has shown that CSCR primarily affects the choroidal circulation, resulting in multifocal areas of choroidal vascular hyperpermeability.
Although CSCR generally is considered a self-limiting and benign condition, some patients experience significant visual impairment. Most episodes of CSCR usually resolve spontaneously within 3 to 4 months. Attempts at treatment serve only to shorten the duration of symptoms and have no effect on the recurrence rate or the final visual acuity.
In this study, 63 eyes of 63 patients with acute symptomatic CSCR underwent PDT with half-dose (3 mg/m2) verteporfin (n = 42) or placebo therapy (n = 21). To enhance the efficacy of PDT while minimizing its side effects, the investigators reduced the dosage of verteporfin and shortened the interval between verteporfin infusion and laser application.
Complete resolution of subretinal fluid at 1 year was achieved in 95% of eyes treated with PDT, compared with 58% in the placebo group. The mean visual acuity and foveal thickness of the PDT-treated group was significantly better than the placebo group at 12 months. All PDT-treated eyes had stable or improved vision, compared with 79% of eyes in the placebo group. No complications were observed in any patients.
The authors conclude that PDT with half-dose verteporfin is an effective treatment option for acute CSCR. The researchers state that their safety-enhanced PDT protocol is among the best of the currently available treatment options for patients with acute symptomatic CSCR.
WHAT IT MEANS TO YOU: This paper offers very encouraging results using a modified PDT protocol that may decrease the risk of adverse effects of the procedure. Others have employed different modifications to the standard PDT protocol in an attempt to decrease the risk of vision loss associated with PDT. Currently, we do not have any evidence that any of these modifications actually do any good. I would not recommend PDT for patients with CSCR until we have studies demonstrating long-term benefit.
There are currently several ongoing clinical trials investigating new drugs and dosing strategies that could result in patients with neovascular AMD requiring fewer injections to maintain control of their disease. Below is a synopsis of information presented on a few such studies at the 2008 Joint Meeting of the American Academy of Ophthalmology and the European Society of Ophthalmology.
LEVEL Study
The LEVEL study is evaluating the ability of Macugen to maintain visual gains provided by previous AMD treatments.
Macgen was given every 6 weeks for 1 year after successful treatment with either Avastin or Lucentis.
Of the 568 patients, 88% completed 1 year of maintenance with Macugen. Visual acuity and central retinal thickness were maintained at week 54. No serious side effects were encountered.
SUSTAIN Study
The SUSTAIN study is investigating the safety and efficacy of Lucentis in wet AMD using a guided, individualized, as-needed, dosing schedule.
Sixty nine patients received 3 monthly injections of Lucentis in the initial fixed-dosing phase and then returned every 4 weeks in the maintenance phase for a total study period of 12 months.
The average number of injections during the 9-month maintenance phase was 2.3 (range: 0 to 7) with no significant loss of vision acuity.
The investigators conclude that their results indicate that flexible dosing based on predefined treatment criteria with monthly monitoring results in fewer injections overall without a loss of effectiveness.
CLEAR-IT 2 Study
The CLEAR-IT 2 study is a phase 2 clinical trial of a new drug for the treatment of wet AMD called VEGF Trap-Eye. This drug is very similar to existing therapies, such as Lucentis, but it appears to have a longer duration of action. Like existing therapies, it is administered by intravitreal injection. VEGF Trap-Eye is still undergoing evaluation and is not yet commercially available.
A total of 159 patients were randomized to 5 groups that received various dosages of VEGF Trap-Eye administered either every 4 weeks or every 12 weeks for an initial 12 week period, then as-needed for an additional 40 weeks.
Responses to the drug were assessed at the conclusion of the initial 12-week fixed-dosing period. A mean improvement in visual acuity of 5.7 letters and a reduction in central retinal thickness to 119 um was noted for all groups combined. For those patients dosed every 12 weeks the effect was not as robust as with monthly dosing.
Patients received, on average, about 2 additional injections over the 40-week as-needed dosing phase following a 12-week fixed-dosing period. Of the patients, 19% received no additional injections after week 12.
It appears that VEGF Trap-Eye is effective at controlling neovascular AMD and may require fewer injections than currently available treatment options.
WHAT IT MEANS TO YOU: Considerable progress is being made in defining new anti-VEGF treatment strategies that reduce the treatment burden without sacrificing effectiveness. Very promising research is going into developing eye drop therapies that could completely eliminate the need for intravitreal injections. Until they become available, the goal is to minimize the number of injections while maintaining control.
New data from the CAPT study finds that persons with greater night vision difficulties have a higher risk of AMD progression.
Previous studies have found that rod photoreceptor loss preceded and was more severe than cone loss in patients with early AMD. Thus, poor night vision caused by rod photoreceptor dysfunction may serve as an indicator for impending AMD progression.
A total of 1052 participants in the Complications of Age-related Macular Degeneration Prevention Trial (CAPT) with good visual acuity and mild AMD (multiple large drusen and vision of 20/40 or better) were administered a 10-item Night Vision Questionnaire. One eye of each participant was randomly assigned to laser treatment, and the other eye was assigned to observation.
Compared with participants with the best night vision (top quartile), participants with the worst night vision (bottom quartile) had a significantly higher risk of 3 or more lines loss in VA, progression of GA, and development of CNV over a 6 year follow-up period. These relationships were independent of other risk factors.
The investigators conclude that patients with mild AMD that have more night vision symptoms are at increased risk of developing loss in VA, CNV, and GA. These findings are consistent with findings that rod photoreceptor degeneration precedes cone degeneration in early AMD.
WHAT IT MEANS TO YOU: There is growing evidence that night vision trouble is a risk factor for progression of AMD. However, there are many things that can give rise to difficulty with night vision beyond macular degeneration. Early cataract and uncorrected refractive error are both common causes of poor night vision. Only an eye exam can determine the reason for the symptoms. Nonetheless, assessing night vision symptoms may be useful in identifying patients with early or intermediate AMD who are at higher risk of progression.
Intravenous Avastin was found to be safe and effective in treating patients with neovascular AMD, according to a new study.
This uncontrolled, prospective study involved 16 patients with neovascular AMD that were treated with intravenous (IV) Avastin. Half the subjects received a higher dose of the drug (5 mg/kg) and the other half received a reduced dose (2.5 mg/kg). All patients received 3 initial IV infusions at 2-week intervals. The main outcome measures were VA, optical coherence tomography (OCT), and fluorescein angiography.
No serious systemic or ocular adverse events were identified. No statistically significant difference was found between the two treatment groups regarding safety, VA, and anatomic outcomes. Both groups experienced significant improvement in visual acuity and reductions in macular thickness that were sustained through 6 months.
The authors conclude that VA, OCT, and angiographic improvements were observed in both treatment groups up to 6 months. Further follow-up is required to evaluate the long-term durability and safety of systemic Avastin for neovascular AMD.
WHAT IT MEANS TO YOU: Intravitreal injection is contraindicated in the presence of active infections of the eye and surrounding structures. Blepharitis, for example, is a common chronic infection of the eyelids. Patients with blepharitis and other infections are believed to be at higher risk of developing endophthalmitis following intravitreal injection. Endophthalmitis is a serious intraocular infection that usually results in blindness. Hopefully we will soon have therapies for AMD that do not require intravitreal injection. But until they become available it is good to know that patients that are unable or unwilling to undergo intravitreal injection have a viable alternative.
There are many new drugs being investigated as potential treatments for wet and dry AMD. Here is some information on new drugs that we may someday use to treat AMD.
OT-551
Othera Pharmaceuticals has recently been issued a patent that covers the company's lead product candidate, OT-551, a topically dosed drug that inhibits oxidative stress and inflammation. Currently, OT-551 is being studied as a treatment to slow the progression of geographic atrophy, the end-stage of dry AMD.
The company has completed enrollment for a phase 2 clinical trial of OT-551 called the OMEGA (OT-551 multi-center evaluation of geographic atrophy) study, in which OT-551 will be evaluated against placebo for treating geographic atrophy.
RETINYLAMINE
An investigational drug called retinylamine slowed the progression of a condition in mice that is very similar to AMD in humans.
Mice that are genetically modified to prevent removal of a by-product of the visual cycle develop a condition that resembles AMD. The visual cycle is the chemical cascade that begins when light is absorbed by photoreceptors and culminates in the transmission of a nerve impulse to the brain. Retinylamine was found to prevent accumulation of toxic visual cycle waste products, and slowed the development of the AMD-like degeneration in the genetically modified mice.
These findings provide direct evidence that toxic by-products of the visual cycle in mice can lead to rapid, progressive retinal degeneration. The investigators state that their research findings suggests that retinylamine could halt the progression of AMD in humans if treatment were started early enough.
INTEGRINS
Integrins are a class of cell surface receptors that play a key role in the regulation of numerous key processes, including cell proliferation, migration, and differentiation. Integrins bind with various components in the extracellular matrix, including basement membrane proteins. Integrin binding can trigger angiogenesis.
Several integrin subtypes have been identified on the endothelium of neovascular vessels in patients with proliferative diabetic retinopathy that are known to be key regulators of angiogenesis. Integrin antagonists have been shown to suppress angiogenesis without harming pre-existing blood vessels in research animals. Integrins have also been identified in human choroidal neovascular membranes.
Integrins appear be a promising target for new drug therapies for proliferative diabetic retinopathy and choroidal neovascularization.
SOMATOSTATIN
A new study reports that the somatostatin analogue RFE-011 effectively inhibited retinal and choroidal neovascularization in mice.
Somatostatin, also known as growth hormone inhibiting hormone, is a hormone that regulates the endocrine system and affects neurotransmission and cell proliferation. Growing evidence suggests that somatostatin acts as an angiogenesis inhibitor in the retina.
RFE-011 is a drug that mimics natural somatostatin activity but is designed to easily penetrate the retina. RFE-011 inhibited retinal neovascularization in a model of diabetic retinopathy in mice. Intravitreal RFE-011 resulted in a 56% reduction in choroidal neovascularization lesion area. In addition, RFE-011 demonstrated transscleral penetration following topical administration.
The investigators conclude that RFE-011 demonstrated antiangiogenic activity in mice.
Lucentis can improve vision and decrease macular edema in patients with non-ischemic central retinal vein occlusion, according to a study published in the journal Ophthalmology. Ten patients with macular edema associated with non-ischemic CRVO were randomly assigned to receive 3 monthly intravitreal injections of either 0.3 or 0.5 mg Lucentis. Additional injections were administered quarterly as needed over the ensuing 21 months. After 3, 6, and 9 months of follow-up, average best corrected visual acuity (BCVA) improved by 12 letters, 3 letters, and 1 letters, respectively, compared with baseline. No significant differences were observed between the two doses. The investigators state that their findings suggest that an interval of 3 months between injections may be too long for most patients. Patients who received re-injection experienced a transient improvement in BCVA that was lost by the next quarterly visit. The researchers write that "our study suggests that frequent and long-term administration of ranibizumab may be necessary for effective disease management in some cases." The investigators state that based on these findings they have decided to investigate an alternative treatment schedule similar to that used in the PrONTO trial.
A study published in the British Journal of Ophthalmology reports good success imaging classic choroidal neovascularization (CNV) in patients with wet AMD using infrared photography. CNV is traditionally diagnosed using fluorescein angiography (FA). Although it is an extraordinarily valuable diagnostic procedure, FA requires administration of intravenous fluorescein dye. Rarely, anaphylactic reactions to the dye may occur. One study estimated that a fatal reaction occurs in one out of every 222,000 procedures. The investigators analyzed 22 eyes of 22 consecutive patients with classic CNV. Infrared pictures revealed a whitish ring surrounding the neovascular lesion in all eyes (22/22). The whitish ring corresponded in all cases to the borders of the CNV defined on the early phase of FA. The ring had an "O-shape" in 15/22 cases (68%) and a "U-shape" in 7/22 cases (32%). The researchers state that infrared photography is a potentially useful noninvasive retinal imaging technology that warrants further study.
A large retrospective case series published in the journal Retina finds that the overall incidence of endophthalmitis associated with office based intravitreal injections of Avastin and Lucentis is 1 in 4,500 injections. All patients receiving at least one injection of intravitreal Avastin or Lucentis at four large clinics were included in this retrospective, consecutive, multicenter case series. Follow-up after each injection was at least 4 weeks. A total of 12,585 injections of Avastin and 14,320 injections of Lucentis were given during the study period. Infectious endophthalmitis developed in three patients after administration of Avastin and in three patients after administration of Lucentis. Four of these patients were culture positive. The overall rate of endophthalmitis was 0.02%. The investigators conclude that the rate of endophthalmitis associated with intravitreal Avastin and Lucentis is low, with an incidence of approximately 1 in 4,500 injections.
Bionic Vision Australia will pursue the development of the most technologically advanced bionic eye to improve the sight of people with degenerative or inherited retinal disease. Bionic Vision Australia's members include the University of Melbourne, the University of New South Wales, the Bionic Ear Institute, Centre for Eye Research Australia and the Victoria Research Laboratory of NICTA. Bionic Vision Australia Chairman, David Penington, said the partnership "brings together Australia's international experts in medical bionics, covering the many disciplines required to develop a safe and technologically advanced device able to restore functional vision." A bionic eye will assist in restoring patient mobility, independence and quality of life by effectively replacing the function of damaged light-sensing cells in the eye. While the clarity and definition of vision will not be equal to normal sight, the device will allow patients to move around, detect large objects and, in time, read text and recognize faces and emotions. Bionic Vision Australia proposes to have its first advanced prototype ready for the first human implant by early 2012.
Lucentis appears safe in the treatment of wet AMD, according to an analysis of 4 large clinical trials. Dr David Boyer presented these findings at the 2008 Joint Meeting of the American Academy of Ophthalmology and the European Society of Ophthalmology. Data from the MARINA, ANCHOR, PIER, and SAILOR trials, including 3701 patients receiving a total of 28,547 Lucentis injections were analyzed. The incidence of intraocular inflammation was somewhat higher for Lucentis-treated patients compared with the sham or photodynamic therapy. The rates of endophthalmitis per injection was very low, ranging from 0% to 0.06% for 2 years of treatment. For nonocular adverse events, the rate of blood clots was 2.7% after year 1 and 4.1% after year 2. In addition, there was a non-significant difference towards a higher rate of stroke in the Lucentis group vs the control group, whereas no such trend was observed for heart attack or arterial thrombotic events overall. "There are no safety signals that should deter physicians from using ranibizumab for patients with neovascular AMD," Dr Diana Do, of Johns Hopkins University, said.
As a potential alternative to intravitreal injection, EyeGate Pharma is developing a noninvasive iontophoretic drug delivery system, the Eye Gate II. EyeGate's drug delivery system works through iontophoresis, a technology currently used to deliver certain medications through the skin. Iontophoretic drug delivery uses the driving force of an applied electric field to help move positively or negatively charged drug molecules through cells and tissues. In order to effectively deliver ophthalmic drugs iontophoretically, the drugs must initially be adapted. EyeGate is working with corporate research partners on reformulating drugs for iontophretic delivery. EyeGate believes it can adapt a variety of drugs for delivery with EyeGate II. Iontophoretic drug delivery is not new, but EyeGate's platform represents the first serious attempt at commercialization of this technology. EyeGate is the only company to have successfully advanced the use of iontophoresis to safely and effectively deliver medication to the anterior and posterior tissues of the eye.
Many innovative systems for the visually impaired have been created by a consortium of companies and research institutes working in the EU-funded ENABLED project. "Our goal was to give blind people more independence by helping to bridge the information gap with the sighted," researcher Wai Yu, of Queen's University in Belfast says. To achieve that, the project partners worked in two broad areas. On the one hand, they developed software applications with tactile, haptic and audio feedback devices to help visually impaired people feel and hear digital maps of where they want to go. On the other hand, they created new haptic and tactile devices to guide them when they are out in the street. One of the patented prototypes, called VITAL, allows users to access a tactile map of an area. Having obtained a 'mental image' of the map from the computer, users can then take the route information with them when they venture outside. For that purpose, the project partners used a GPS device to guide users as they walk around, much like a navigation system in a car. The aim of the ENABLED team's research is not to replace tried and tested aids for the blind, such as canes and guide dogs, but to complement them with new technologies that can improve the independence and autonomy of the visually impaired.
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