Clinical Trials in RVO

Retinal Vein Occlusion Clinical Studies

Retinal vein occlusion (RVO) is the second most common retinal vascular disorder after diabetic retinopathy. [Blair.2020] [Cochran.2020] RVO commonly leads to vision loss in older patients; its two subtypes are branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). [Blair.2020] For BRVO, treatment is primarily aimed at preventing the complications that cause vision loss, such as macular edema and neovascularization. [Cochran.2020] In CRVO, elevated levels of vascular endothelial growth factor (VEGF) leads to neovascularization. [Blair.2020] In both types, treatment often involves intravitreal injections of anti-VEGF agents.

In 2010, ranibizumab became the first anti-VEGF agent approved by the FDA for this indication, followed by aflibercept in 2014. [Sophie.2013] [EYLEA.PI.2019] To date, bevacizumab is not approved to treat RVO, but remains used off-label for this indication. Intravitreal dexamethasone 0.7 mg is the only corticosteroid currently approved to treat RVO. This section lists the most relevant clinical studies on BRVO, with the most relevant clinical studies on CRVO following.

Click on the study name to see more details about each particular study. To enhance visibility of graphs and tables, click on the image to enlarge for expanding viewing.

Branch Retinal Vein Occlusion Clinical Studies (anti-VEGF)

Central Retinal Vein Occlusion Clinical Studies (anti-VEGF)

Post-hoc and Extension Study Analyses (Intravitreal Anti-VEGF injections)

Retinal Vein Occlusion Clinical Studies (Intravitreal Corticosteroids)

References

  • Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology 2013;120:1057-1063.
  • Blair K, Czyz CN. Central Retinal Vein Occlusion. 2020 May 23. In: StatPearls [Internet]. Treasure island (FL): Statpearls publishing; 2020 Jan–. PMID: 30252241
  • 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 [published correction appears in Ophthalmology. 2012 Nov;119(11):2204]. Ophthalmology. 2012;119(5):1024-1032.
  • 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. Ophthalmology. 2010;117:1124-1133.e1.
  • Brown DM, Heier JS, Clark WL, et al. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013;155(3):429-437.e7.
  • BVOS Study Group. Argon laser photocoagulation for macular edema in branch vein occlusion. Am J Ophthalmol. 1984;98(3):271-282.
  • Campochiaro PA, Brown DM, Awh CC, et al. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011;118:2041-2049.
  • Campochiaro PA, Clark WL, Boyer DS, et al. Intravitreal aflibercept for macular edema following branch retinal vein occlusion: the 24-week results of the VIBRANT study. Ophthalmology. 2015;122(3):538-544.
  • Campochiaro PA, Hafiz G, Mir TA, et al. Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion: The Relate Trial. Ophthalmology 2015;122:1426-1437.
  • 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(6):1102-1112.
  • Cochran ML, Mahabadi N, Czyz CN. Branch Retinal Vein Occlusion. 2020 Aug 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan–. PMID: 30570991
  • Central Vein Occlusion Study Group (CVOSG). Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995;102:1425-1433.
  • EYLEA [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; August 2019.
  • Flaxel CJ, Adelman RA, Bailey ST, et al. Retinal vein occlusions preferred practice pattern®. Ophthalmology. 2020;127(2):P288-P320.
  • Haller JA, Bandello F, Belfort R Jr, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010;117:1134-1146.e3.
  • Haller JA, Bandello F, Belfort R Jr, et al. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology. 2011;118:2453-2460.
  • 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(4):802-809.
  • Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study [published correction appears in Ophthalmology. 2014 Nov;121(11):2293]. Ophthalmology. 2014;121(7):1414-1420.e1.
  • Holz FG, Roider J, Ogura Y, et al. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study [published correction appears in Br J Ophthalmol. 2015 Dec;99(12):1746]. Br J Ophthalmol. 2013;97(3):278-284.
  • Hykin P, Prevost AT, Vasconcelos JC, et al. Clinical Effectiveness of Intravitreal Therapy with Ranibizumab Vs Aflibercept Vs Bevacizumab for Macular Edema Secondary to Central Retinal Vein Occlusion: A Randomized Clinical Trial. JAMA Ophthalmol. 2019;137:1256-1264.
  • LUCENTIS® (ranibizumab injection) full U.S. prescribing information. Genentech, Inc. March 2018.
  • OZURDEX® (dexamethasone intravitreal implant) full U.S. prescribing information. Allergan. May 2018.
  • Rajagopal R, Shah GK, Blinder KJ, et al. Bevacizumab versus ranibizumab in the treatment of macular edema due to retinal vein occlusion: 6-month results of the CRAVE study. Ophthalmic Surg Lasers Imaging Retina. 2015;46(8):844-850.
  • SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study Report 5. Arch Ophthalmol. 2009;127(9):1101-1114.
  • SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6. Arch Ophthalmol. 2009;127(9):1115-1128.
  • Scott IU, VanVeldhuisen PC, Ip MS, et al. SCORE2 report 2: study design and baseline characteristics. Ophthalmology. 2017;124(2):245-256.
  • Sophie R, Campochiaro PA. Treatment of macular edema following branch retinal vein occlusion. US Ophthalmic Rev. 2013;6(2):148-153.
  • Vader MJC, Schauwvlieghe AME, Verbraak FD, et al. Comparing the efficacy of bevacizumab and ranibizumab in Patients with retinal vein occlusion: The bevacizumab to ranibizumab in retinal vein occlusions (Brvo) study, a randomized trial. Ophthalmol Retina. 2020;4:576-587.
  • Wykoff CC, Ou WC, Wang R, et al. Peripheral Laser for Recalcitrant Macular Edema Owing to Retinal Vein Occlusion: The Wave Trial. Ophthalmology. 2017;124:919-921.