LAS VEGAS — For patients with diabetic macular edema, long-term response to vascular endothelial growth-factor (VEGF) inhibitors can be predicted after just three injections, according to a post hoc analysis of data from Protocol I of the Diabetic Retinopathy Clinical Research Network (DRCR.net).
  
Patients who did not respond to three monthly anti-VEGF injections were destined to remain relatively unresponsive at 3 years, said Pravin Dugel, MD, from the University of Southern California Keck School of Medicine in Los Angeles and Retinal Consultants of Arizona in Phoenix.
  
This is a group of patients who might benefit from treatments that have an alternate mode of action, he pointed out.
  
Dr Dugel presented results from the phase 3 Early Anti-VEGF Response and Long-term Efficacy (EARLY) study here at the American Academy of Ophthalmology 2015 Annual Meeting.
  
He and his colleagues evaluated 854 eyes from 691 patients with diabetic macular edema treated with ranibizumab according to an established protocol over a period of 3 years.
  
The team assessed study eyes for best corrected visual acuity after 3 months and throughout the study period. The results were striking; patients “tracked” according to their 12-week response.
  
In the group of patients who gained at least 10 letters after three injections, this strong response at 12 weeks was maintained during the 3-year study period. In the group of patients who gained five to nine letters, improvement was limited at 3 years. And in the group of patients who gained four letters or less, the benefit was minimal at 3 years, Dr Dugel reported.
  
“The point here is that three injections, after 12 weeks, can very confidently predict what’s going to happen to the patient — not just for 1 year, but for up to 3 years,” he told Medscape Medical News.
  
  
Change in Mean Best Corrected Visual Acuity Over Time
  
Mean Letters Gained 0 to 4 Letter Group (n = 135) 5 to 9 Letter Group (n = 79) ≥10 Letter Group (n = 126)
At 3 months 0.3 6.9 15.2
At 1 year 2.8 8.2 16.5
At 3 years 3.0 8.2 13.8
  
  
After multivariate adjustment, there was a significant correlation in best corrected visual acuity gain for all three groups of patients between week 12 and years 1 and 3 (P < .001).    "The number gaining less than five letters was around 39%," Dr Dugel reported. "Overall, these patients do well on anti-VEGF agents, but when you look at the outcomes with more granularity, you see that many don't. Right now, this is the only way to predict who will be in that group."    All anti-VEGF agents are relatively similar in efficacy in this disease. There's no evidence for switching, and no evidence that switching from one anti-VEGF agent to another is better. On the basis of these results, Dr Dugel said that clinicians might want to consider therapies with alternative modes of action for patients with diabetic macular edema who are inadequately responsive after three injections.    In fact, if a patient does not respond to an anti-VEGF agent after three injections, "consider alternative modes of therapy," he said.    But Dr Dugel said he would not switch to another anti-VEGF. "All anti-VEGF agents are relatively similar in efficacy in this disease. There's no evidence for switching, and no evidence that switching from one anti-VEGF agent to another is better," he explained.    A lack of response probably indicates a different disease mechanism at work, Dr Dugel reported.    Diabetic macular edema "may evolve from a condition that is primarily permeability-driven to one that is primarily inflammatory-driven, and in a new patient, you have no idea where they are on this spectrum. The patient may have thrown the multifactorial switch and may now be in the inflammatory phase as opposed to the early permeability phase of disease," he pointed out. "This is where steroids come in."    Dr Dugel said that the dexamethasone intravitreal implant (Ozurdex, Allergan) is the natural choice for the initial intervention. After that, there is fluocinolone acetonide (Iluvien, Alimera Sciences), which has also been approved by the US Food and Drug Administration.    This analysis of the EARLY data confirms what Ninel Gregori, MD, from the Bascom Palmer Eye Institute in Miami, has been doing for some time.    "By 3 months, I do think you know how a patient is going to do on anti-VEGF agents," she told Medscape Medical News. "This is how I have been managing patients already. What I do with my patients, in particular my diabetics, is to give 3 months of injections with bevacizumab, then evaluate. If they have improved, great, I continue the treatment. If they have not, I switch to a different anti-VEGF agent, usually aflibercept, and inject another three times. If there is still no change, I may go to a steroid next," she said.    Although this study was based on DRCR.net data, the analysis was not reviewed or approved by DRCR.net. Dr Dugel reports consulting for Allergan, Abbott Medical Optics, Acucela, Alcon Laboratories, Alimera Sciences, Digisight, Genentech, Novartis Pharmaceuticals, Ophthotech, Ora, Regeneron, and ThromboGenics. Dr Gregori has disclosed no relevant financial relationships.    American Academy of Ophthalmology (AAO) 2015 Annual Meeting. Presented November 14, 2015.    Source: Medscape

During a press conference led by retinal disease specialists and sponsored by Bayer Healthcare, experts announced the approval of the latest treatment for diabetic retinopathy in patients with diabetic macular edema (DME) in Egypt.
  
Dr Hany Hamza, Professor of Ophthalmology at Cairo University and Retinal Diseases Consultant said, “with nearly 21 million people worldwide suffering from DME, phase 3 of VIVID-DME and VISTA-DME clinical trials revealed that aflibercept offers diabetes patients suffering from impaired vision a new treatment option allowing them to proactively manage disease progression and achieve sustained improvement.”
  
Egypt now joins 30 other countries which have approved aflibercept which was authorized for DME treatment by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in August 2014.
  
“Diabetic Macular Edema (DME) is a common complication of diabetes, causing damage to the retina, which may lead to poor vision and vision loss,” said Dr Hamza. “Visual impairment resulting from DME affects nearly 3% of diabetes patients worldwide, making DME a leading cause of vision loss in working-age adults.”
  
“In Egypt DME is a serious challenge; it affects nearly 30% of a total of 7.5 million people living with diabetes in the country. DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This in turn can cause severe vision loss or blindness,” added Dr Hamza.
  
Dr Magdy Moussa, Professor of Ophthalmology at Tanta University and Retinal Diseases Consultant shed light on the results of Phase 3 of VIVID-DME and VISTA-DME clinical trials, “after one year of regular therapy, patients treated with aflibercept showed significant improvements gaining, on average, the ability to read approximately two additional lines on an eye chart. Moreover, 33% of patients regained the ability to read three additional lines after only eight injections.”
  
Aflibercept which is injected into the eye once a month, for an initial five months, then once every two months, minimizes the development of abnormal retinal vessels, by blocking the vascular endothelial growth factor (VEGF), one of the natural growth factors in the body which play a significant role in diabetic retinopathy incidence. By reducing the rate of development of new blood vessels, leakage is minimized or prevented.
  
“Aflibercept represents an effective and comprehensive treatment for DME; it is currently the only treatment option for diabetic retinopathy in patients with DME that is approved for bimonthly dosing after an initial monthly dosing period. Moreover, current treatments which block VEGF only inhibit the VEGF-A protein, whereas aflibercept inhibits all the different VEGF-A proteins, in addition to PlGF,” said De Moussa.
  
“People living with diabetes must closely monitor their blood sugar levels and go for eye checkups once every year,” said Dr Hamza. “Early detection achieves the best treatment outcomes – patients who discover the disease early are successful in controlling it and preventing loss of vision.”
  
Source: Albawaba