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© 2012 Direct One Communications, Inc. All rights reserved. 1 Update on Anti-VEGF Therapy in Diabetic Macular Edema, Neovascular AMD, and Retinal Vein Occlusion Jonathan S. Chang, MD Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida A REPORT FROM THE 2012 ANNUAL MEETING OF THE ASSOCIATION FOR RESEARCH IN VISION AND OPHTHALMOLOGY
© 2012 Direct One Communications, Inc. All rights reserved. 2 A New Focus on Ophthalmic Disease Use of anti-vascular endothelial growth factor (anti- VEGF) agents has become a mainstay in treating several common retinal diseases. This drug class initially was used to manage neovascular age-related macular degeneration (AMD). 1–3 Its value recently was affirmed for treating both branch retinal vein occlusion (BRVO) 4 and central retinal vein occlusion (CRVO). 5 Further clinical data support their use in managing diabetic macular edema (DME). 6
© 2012 Direct One Communications, Inc. All rights reserved. 3 Novel Drugs for Ophthalmic Indications Ranibizumab has been approved by the US Food and Drug Administration (FDA): » To treat patients with neovascular AMD » For macular edema following retinal vein occlusion (RVO) » For DME (August 2012) Aflibercept (VEGF Trap-Eye) is approved by the FDA for treating neovascular AMD. Intravitreal bevacizumab is widely used off-label for the treatment of these conditions, especially neovascular AMD.
© 2012 Direct One Communications, Inc. All rights reserved. 4 Clinical Trials of VEGF Inhibitors Several recent studies offered additional insight into the use of anti-VEGF agents. The READ, 3,7 RISE, 8 and RIDE 8 trials involved the use of ranibizumab in patients with DME. The DA VINCI trial 9 demonstrated the effect of aflibercept therapy in DME patients. The 2-year results of the CATT trial 10 compared use of bevacizumab with ranibizumab therapy in AMD patients.
© 2012 Direct One Communications, Inc. All rights reserved. 5 Clinical Trials of VEGF Inhibitors Investigators involved in the VIEW 1 and VIEW 2 studies 11 reported on the use of aflibercept in patients with neovascular AMD. The management of RVO changed after analysis of the CRUISE 4 and BRAVO 5 study results. Further information has been gathered in the HORIZON study. 12 Questions about the management of patients diagnosed with retinal disease remain.
© 2012 Direct One Communications, Inc. All rights reserved. 6 Issues Involved in Using VEGF inhibitors Monthly versus as-needed dosing The choice of an anti-VEGF agent for treating each condition Corticosteroid and laser therapy in patients affected by RVO and DME The safety of intravitreal injections of VEGF inhibitors
© 2012 Direct One Communications, Inc. All rights reserved. 7 Diabetic Macular Edema
© 2012 Direct One Communications, Inc. All rights reserved. 8 Diabetic Macular Edema: DRCR Trial In the Diabetic Retinopathy Clinical Research Network (DRCR) protocol I, 6,13 investigators compared sham therapy plus prompt focal laser treatment with: » Ranibizumab plus prompt laser therapy » Ranibizumab plus deferred laser treatment » Triamcinolone plus prompt laser therapy Two-year follow-up data recently showed improved visual acuity and central foveal thickness in both ranibizumab groups as compared with those receiving sham plus laser therapy or triamcinolone plus laser therapy. 14
© 2012 Direct One Communications, Inc. All rights reserved. 9 Diabetic Macular Edema: RISE and RIDE Trials RISE 8 and RIDE 8 were two parallel studies comparing the use of 0.3 or 0.5 mg of ranibizumab given monthly with sham therapy for DME. In the RIDE trial, patients receiving 0.3 and 0.5 mg of ranibizumab gained 8.6 and 9.7 letters of visual acuity, respectively. Similar results were reported in the RISE trial, with patients given 0.3 mg of ranibizumab gaining 10.0 letters and those given 0.5 mg gaining 9.3 letters. Patients receiving ranibizumab at either dose level showed improvement in visual acuity and retinal thickness and a reduction in diabetic retinopathy.
© 2012 Direct One Communications, Inc. All rights reserved. 10 Diabetic Macular Edema: READ 3 Trial The READ 3 trial 7 compared two different ranibizumab doses in patients with DME. Patients were randomized to groups receiving 0.5 or 2.0 mg of ranibizumab monthly for 6 months. At month 6, patients in the 0.5-mg group gained a mean of 8.72 letters, whereas those in the 2.0-mg group gained a mean of 7.35 letters. At month 12, patients in the 0.5-mg group gained letters as compared with the 7.39 letters gained by the 2.0-mg group (P = 0.03).
© 2012 Direct One Communications, Inc. All rights reserved. 11 Diabetic Macular Edema: BOLT Study The BOLT study 15 compared the use of bevacizumab with focal laser therapy in patients with DME. Patients were randomized to groups receiving either bevacizumab or macular laser therapy and were followed for 2 years. Patients in the bevacizumab group gained a mean of 8.6 letters, whereas those in tThe macular laser therapy group lost a mean of 0.5 letters. Central foveal thickness also was reduced in the bevacizumab group as compared with the laser treatment group.
© 2012 Direct One Communications, Inc. All rights reserved. 12 Diabetic Macular Edema: DA VINCI Study Results from the DA VINCI trial 9 demonstrated improvement in the eyes of patients with DME who used aflibercept as compared with patients who underwent focal laser therapy.
© 2012 Direct One Communications, Inc. All rights reserved. 13 Diabetic Macular Edema: Treatment Considerations Many ophthalmologists prefer to administer treatment at regular intervals instead of as needed in patients affected with a chronic process like DME. Persistent edema appears to be more common among patients with DME than in those with neovascular AMD, even in eyes treated regularly. The clinician’s threshold for residual edema may be greater, because the two diseases have different natural histories.
© 2012 Direct One Communications, Inc. All rights reserved. 14 Diabetic Macular Edema: Treatment Considerations Patients with DME tend to be young: » They may receive a considerable number of injections over their lifetime. » Frequent office visits can interrupt their daily lives. The current VIVID-DME (ClinicalTrials.gov NCT ) and VISTA DME (ClinicalTrials.gov NCT ) trials are examining use of a loading dose of aflibercept every month for 6 months followed by dosing every 6 months. » Data on these phase III trials should be available in the coming years.
© 2012 Direct One Communications, Inc. All rights reserved. 15 Diabetic Macular Edema: Corticosteroid Therapy Corticosteroid therapy continues to be an option for patients with DME. However, it tends to be used now in individuals who do not respond to anti-VEGF treatment. Increased intraocular pressure and cataracts continue to be the main adverse effects related to the use of corticosteroids.
© 2012 Direct One Communications, Inc. All rights reserved. 16 Diabetic Macular Edema: FAME Trial The FAME trial 16 examined the use of a fluocinolone acetonide implant in patients with DME. The results demonstrated efficacy with both a 0.2 and 0.5 µg/d implant. At 2 years, a greater than 15-letter improvement in visual acuity was achieved in: » 28.7% of patients receiving 0.2 µg/d of fluocinolone » 28.6% of patients receiving 0.5 µg/d of fluocinolone » 16.2% of the sham treatment group (P = for each) 62% of patients receiving 0.2 µg/d did not require treatment for increased intraocular pressure.
© 2012 Direct One Communications, Inc. All rights reserved. 17 Diabetic Macular Edema: Corticosteroid Therapy The FDA has not approved the use of fluocinolone acetonide implants for treating DME because of insufficient safety data. Marketing of the implant for this indication is approved in Europe. In selected patients, corticosteroid treatment remains an option.
© 2012 Direct One Communications, Inc. All rights reserved. 18 Neovascular AMD
© 2012 Direct One Communications, Inc. All rights reserved. 19 Neovascular AMD: Clinical Data and Options AMD is the leading cause of blindness in the United States and in other developed countries. 17 During the past few months, data from several large trials have impacted treatment options. » Use of ranibizumab for neovascular (exudative) AMD was first reported in the MARINA 2 and ANCHOR 3 studies. » Frequency of ranibizumab dosing has been examined in the PIER, 18 PrONTO, 19 SUSTAIN, 20 EXCITE, 21 and HORIZON 22 trials. As anti-VEGF treatment alternatives have expanded, ophthalmologists now have 3 options: ranibizumab, aflibercept, and off-label bevacizumab.
© 2012 Direct One Communications, Inc. All rights reserved. 20 Neovascular AMD: The VIEW Trials Results from the VIEW 1 and VIEW 2 trials, which compared the use of aflibercept with ranibizumab therapy for exudative AMD, were reported recently. 11 These parallel, noninferiority trials randomized a total of 1,217 North American patients to one of four treatment groups: » 0.5 mg of ranibizumab monthly » 0.5 mg of aflibercept monthly » 2 mg of aflibercept monthly » Three monthly 2-mg aflibercept injections given as a loading dose followed by 2 mg of aflibercept every 2 months
© 2012 Direct One Communications, Inc. All rights reserved. 21 Neovascular AMD: The VIEW Trials In 94%–96% of patients, moderate vision loss was prevented. The three aflibercept groups had results that were noninferior to those observed in the ranibizumab group. Patients receiving 2.0 mg of aflibercept monthly experienced a 10.9-letter gain as compared with an 8.1-letter gain observed in patients given monthly ranibizumab. 11 This difference was statistically significant.
© 2012 Direct One Communications, Inc. All rights reserved. 22 Neovascular AMD: The VIEW Trials The VIEW 2 trial enrolled 1,240 patients in Europe, Asia, and Latin America and had outcomes similar to those of the VIEW 1 trial. 11 Both studies had adverse event rates that were similar to each other and to those of prior studies of anti-VEGF therapy. Aflibercept may be an option in patients who do not respond well to ranibizumab or bevacizumab.
© 2012 Direct One Communications, Inc. All rights reserved. 23 Neovascular AMD: The CATT Trial Two-year results of the CATT trial, 10 a study funded by the National Eye Institute, recently were presented at the 2012 ARVO meeting. A total of 1,185 patients with neovascular AMD were randomly assigned to one of four treatment groups: » 0.5 mg of ranibizumab monthly » 1.25 mg of bevacizumab monthly » 0.5 mg of ranibizumab as needed » 1.25 mg of bevacizumab as needed
© 2012 Direct One Communications, Inc. All rights reserved. 24 Neovascular AMD: The CATT Trial The as-needed groups were seen every 4 weeks and received injections when: » New fluid was present on optical coherence tomography (OCT) » New or persistent hemorrhage occurred » Decreased visual acuity or new leakage was seen on fluorescein angiography After 1 year, the monthly groups were divided into monthly and as-needed treatment cohorts for 1 year.
© 2012 Direct One Communications, Inc. All rights reserved. 25 Neovascular AMD: The CATT Trial After 2 years of therapy: » The monthly ranibizumab group demonstrated a gain of 8.8 letters. » The monthly bevacizumab group gained 7.8 letters. » The ranibizumab as-needed group gained 6.7 letters. » The bevacizumab as-needed group gained 5 letters.
© 2012 Direct One Communications, Inc. All rights reserved. 26 Neovascular AMD: The CATT Trial Patients receiving monthly injections gained 2.4 letters more than did those given ranibizumab or bevacizumab as needed (P = 0.046). Mean retinal thickness on OCT was 29 μm less in the monthly treatment groups than in patients receiving ranibizumab or bevacizumab as needed This difference also was statistically significant.
© 2012 Direct One Communications, Inc. All rights reserved. 27 Neovascular AMD: The CATT Trial No evidence of fluid was found on OCT in: » 45.5% of the monthly ranibizumab group » 30.2% of the monthly bevacizumab group » 22.3% of the as-needed ranibizumab group » 13.9% of the as-needed bevacizumab group Over 2 years, the mean number of injections in the monthly ranibizumab and bevacizumab groups was 22.4 and 23.4, respectively. The as-needed ranibizumab and bevacizumab groups received a mean of 12.6 and 14.1 injections, respectively.
© 2012 Direct One Communications, Inc. All rights reserved. 28 Neovascular AMD: The CATT Trial Based on the results of the CATT trial, there is a 2.4-letter difference between monthly dosing and as-needed dosing in patients with neovascular AMD. The results also affirmed the effectiveness of off-label bevacizumab in treating neovascular AMD. It is not known whether differences in results between groups given monthly or as-needed dosing would increase further after 2 years. Given that many patients with neovascular AMD are treated for longer than 2 years, clinicians are greatly interested in the long-term effects of therapy.
© 2012 Direct One Communications, Inc. All rights reserved. 29 Neovascular AMD: The CATT Trial Geographic atrophy increased in the monthly dosing groups when compared with the as-needed dosing groups. » It is not clear whether this finding is related to improved visualization of geographic atrophy due to a decreased amount of fluid or to a process associated with chronic anti- VEGF therapy. » Geographic atrophy is a factor to consider in future trials of VEGF inhibitors. » Other imaging may be useful in this regard. The study also did not address the efficacy of the commonly used “treat-and-extend” protocol for administering ranibizumab or bevacizumab.
© 2012 Direct One Communications, Inc. All rights reserved. 30 Retinal Vein Occlusion
© 2012 Direct One Communications, Inc. All rights reserved. 31 Retinal Vein Occlusion: FDA-Approved Drugs for Treating RVO In 2009, the FDA approved the use of a dexamethasone intravitreal implant for the treatment of macular edema following RVO. The following year, it approved the use of intravitreal ranibizumab for the same indication. In the past, RVO initially would have been treated with observation. Now, based on data from the CRUISE and BRAVO studies, 4,5 prompt treatment of RVO with ranibizumab has become commonplace.
© 2012 Direct One Communications, Inc. All rights reserved. 32 Retinal Vein Occlusion: Clinical Trials Investigators involved in the COPERNICUS study 23 reported data showing an improvement in macular edema after 6 months of monthly aflibercept therapy in patients with CRVO. Treatment regimens for RVO now typically start with monthly injections of anti-VEGF agents before patients are switched to as-needed dosing with monthly monitoring.
© 2012 Direct One Communications, Inc. All rights reserved. 33 Retinal Vein Occlusion: Clinical Trials Based on data from the HORIZON trial, 12,22 in which patients initially enrolled in CRUISE or BRAVO continued therapy with as-needed treatment, fewer injections were required after the initial 12 months of therapy. Focal laser therapy often is used adjunctively after 5–6 months of initial therapy.
© 2012 Direct One Communications, Inc. All rights reserved. 34 Retinal Vein Occlusion: Monitoring Retinal Nonperfusion Patients with CRVO or BRVO who are given anti- VEGF therapy have shown differences in central nonperfusion. » However, these discrepancies have not been fully evaluated in clinical trials. Peripheral retinal nonperfusion also may recover with anti-VEGF therapy. » This finding, however, also has not been fully studied. Retinal nonperfusion often is a precursor to neovascularization and may be a measure for future studies.
© 2012 Direct One Communications, Inc. All rights reserved. 35 Retinal Vein Occlusion: Monitoring Retinal Nonperfusion Retinal hemorrhage resolution improves with anti- VEGF therapy. » The mechanism for this clearance is not fully understood. The use of scatter and focal laser photocoagulation also is important in these patients.
© 2012 Direct One Communications, Inc. All rights reserved. 36 Safety of Anti-VEGF Therapy
© 2012 Direct One Communications, Inc. All rights reserved. 37 Safety of Anti-VEGF Therapy In recent clinical trials evaluating VEGF inhibition in patients with DME, exudative AMD, or RVO, endophthalmitis occurred in about 1% of patients, about the same frequency as reported in prior studies. As previously mentioned, increased geographic atrophy has been observed in patients with neovascular AMD receiving monthly injections of ranibizumab or bevacizumab. 10 » However, this finding has not been reported in patients who were treated with VEGF inhibitors for DME or RVO. » It is not clear whether this increase in geographic atrophy is directly related to anti-VEGF therapy. Systemic adverse effects in patients with neovascular AMD previously were evaluated in the SAILOR trial. 24
© 2012 Direct One Communications, Inc. All rights reserved. 38 Safety of Anti-VEGF Therapy Systemic adverse effects in patients with neovascular AMD previously were evaluated in the SAILOR trial. 24 In the CATT trial, % of the bevacizumab group and 31.7% of those receiving ranibizumab developed one or more serious systemic adverse events, a statistically significant difference (P = 0.004). 10 Serious adverse events included: » Death (6.1% for bevacizumab vs 5.3% for ranibizumab) » Arterial thrombotic events (5.0% vs 4.7%) » Venous thrombotic events (1.7% vs 0.5%) » Hypertension (0.7% vs 0.5%)
© 2012 Direct One Communications, Inc. All rights reserved. 39 Conclusion
© 2012 Direct One Communications, Inc. All rights reserved. 40 Conclusion The use of anti-VEGF therapy continues to be a mainstay of medical retina therapy. Increased use of VEGF inhibitors for retinal diseases has led to questions about: » Their efficacy and safety » Frequency of treatment » The possible application of “treat-and-extend” therapy » The potential role of corticosteroid implants in treating DME and RVO A better understanding of the VEGF pathways and ways that VEGF affects normal physiology will increase our knowledge of these diseases.
© 2012 Direct One Communications, Inc. All rights reserved. 41 Conclusion In DME, there appears to be a role for anti-VEGF agents. 6–8,13–15 Regular monthly injections of these agents seem to produce greater benefit than does as-needed dosing. Recent data from several large AMD trials demonstrated the efficacy of aflibercept 11 and validated the off-label use of bevacizumab for neovascular AMD, albeit at the risk of a greater frequency of serious systemic adverse events when compared with ranibizumab. 10 Monthly dosing also appeared to produce better outcomes in AMD than did as-needed dosing. 10
© 2012 Direct One Communications, Inc. All rights reserved. 42 Conclusion For RVO, anti-VEGF agents have changed treatment planning from observation to earlier intervention. Further investigation is needed to determine long- term treatment strategies for these patients. Recent trials have not demonstrated any higher frequency of adverse systemic effects or additional adverse events from VEGF-inhibitor therapy. Future studies will supply greater details on the safety and efficacy of these agents and optimal dosing schedules.
© 2012 Direct One Communications, Inc. All rights reserved. 43 References 1.Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR. Pegaptanib for neovascular age- related macular degeneration. VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. N Engl J Med. 2004;351:2805– Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419– Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432– Campochiaro PA, Heier JS, Feiner L, et al. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1102– Brown DM, Campochiaro PA, Singh RP, et al. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. BRAVO Investigators. Ophthalmology. 2010;117:1124– Elman MJ, Aiello LP, Beck RW, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Diabetic Retinopathy Clinical Research Network. Ophthalmology. 2010;117:1064– Do DV, Campochiaro PA, Boyer DS, et al. Six month results of the READ 3 study: ranibizumab for edema of the macular in diabetes. Presented at the 2012 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO); May 6–10, 2012; Fort Lauderdale, Florida. Abstract Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012;119:789– Do DV, Nguyen QD, Boyer D, et al. One-year outcomes of the DA VINCI study of VEGF Trap-Eye in eyes with diabetic macular edema. DA VINCI Study Group. Ophthalmology. 2012;119:1658– Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age- related macular degeneration: two-year results. Ophthalmology. 2012;119:1388–1398.
© 2012 Direct One Communications, Inc. All rights reserved. 44 References 11.Heier JS. VEGF Trap-Eye for AMD: VIEW 1/VIEW 2 studies. Presented at the 2011 Annual Meeting of the American Academy of Ophthalmology (AAO) Retina Subspecialty Day; October 21, 2011; Orlando, Florida. Abstract Heier JS, Campochiaro PA, Yau L, et al. Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial. Ophthalmology. 2012;119:802– Googe J, Brucker AJ, Bressler NM, et al. Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation. Diabetic Retinopathy Clinical Research Network. Retina. 2011;31:1009– Elman MJ, Bressler NM, Qin H, et al. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011;118:609– Rajendram R, Fraser-Bell S, Kaines A, et al. A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Arch Ophthalmol Epub ahead of print. 16.Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626– Friedman DS, O’Colmain BJ, Munoz B, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004;122:564– Abraham P, Yue H, Wilson L. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2. Am J Ophthalmol. 2010;150:315– Lalwani GA, Rosenfeld PJ, Fung AE, et al. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO study. Am J Ophthalmol. 2009;148:43–58.
© 2012 Direct One Communications, Inc. All rights reserved. 45 References 20.Holz FG, Amoaku W, Donate J, et al. Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study. Ophthalmology. 2011;118:663– Schmidt-Erfurth U, Eldem B, Guymer R, et al. Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration: the EXCITE study. Ophthalmology. 2011;118:831– Singer MA, Awh CC, Sadda S, et al. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology. 2012;119:1175– Boyer D, Heier J, Brown DM, et al. Vascular endothelial growth factor trap-eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012;119:1024– Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009;116:1731–1739.
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