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Intraocular Pressure-Related Events After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Report 16 on a Secondary Analysis of a Randomized Clinical Trial

Archives of ophthalmology (1960), 2021-12, Vol.139 (12), p.1285 [Peer Reviewed Journal]

Copyright American Medical Association Dec 2021 ;ISSN: 2168-6165 ;EISSN: 2168-6173 ;EISSN: 1538-3601 ;DOI: 10.1001/jamaophthalmol.2021.4395 ;PMID: 34709363

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  • Title:
    Intraocular Pressure-Related Events After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Report 16 on a Secondary Analysis of a Randomized Clinical Trial
  • Author: Aref, Ahmad A ; Scott, Ingrid U ; VanVeldhuisen, Paul C ; King, Jacquie ; Ip, Michael S ; Blodi, Barbara A ; Oden, Neal L
  • Subjects: Aged ; Angiogenesis Inhibitors - therapeutic use ; Bevacizumab ; Bevacizumab - adverse effects ; Clinical trials ; Cost-benefit analysis ; Edema ; Female ; Glaucoma ; Glaucoma - complications ; Humans ; Intraocular Pressure ; Intravitreal Injections ; Laser surgery ; Lasers ; Macular Edema - diagnosis ; Macular Edema - drug therapy ; Macular Edema - etiology ; Male ; Occlusion ; Receptors, Vascular Endothelial Growth Factor - therapeutic use ; Retina ; Retinal Vein Occlusion - complications ; Retinal Vein Occlusion - diagnosis ; Retinal Vein Occlusion - drug therapy ; Surgery ; Tomography, Optical Coherence ; Vascular endothelial growth factor ; Visual Acuity
  • Is Part Of: Archives of ophthalmology (1960), 2021-12, Vol.139 (12), p.1285
  • Description: Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are used to treat a variety of posterior segment conditions, including some associated with glaucoma, such as macular edema due to central retinal vein occlusion (CRVO). Therefore, information regarding intraocular pressure (IOP)-related events associated with anti-VEGF therapies is important to help balance the risks and benefits over the course of therapy. To investigate IOP-related events among participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). Secondary analysis of a randomized clinical trial that included 312 participants with macular edema secondary to CRVO or hemiretinal vein occlusion (HRVO) who were not taking IOP-lowering medications at baseline. First randomization occurred on September 14, 2014, and contained data through data freeze on April 1, 2020. Analysis took place from April 2020 through December 2020. Study participants were initially randomized to 6 monthly intravitreal injections of aflibercept or bevacizumab. At month 6, protocol-defined good responders were rerandomized to continued monthly or treat-and-extend dosing of their originally assigned study drug, and protocol-defined poor or marginal responders were switched to alternative treatment. After month 12, participants were treated as per investigator discretion. Three different outcomes: (1) IOP elevation more than 10 mm Hg from baseline, (2) IOP to a level higher than 35 mm Hg, and (3) IOP-lowering incisional or laser surgery. Of the 312 participants meeting inclusion criteria (138 [44.2%] were female; mean [SD] age, 67.8 [12.1] years), 25 (8.0%) had IOP elevation more than 10 mm Hg over baseline through month 60, and 5 (1.6%) had IOP higher than 35 mm Hg. The 60-month Kaplan-Meier cumulative incidence of IOP elevation more than 10 mm Hg over baseline was 0.13 (95% CI, 0.08-0.19), and the 60-month Kaplan-Meier cumulative incidence of IOP higher than 35 mm Hg was 0.02 (95% CI, 0.01-0.06), and did not differ among participants initially randomly assigned to receive aflibercept or bevacizumab. Three participants (1.0%) underwent IOP-lowering incisional surgery, and 3 participants (1.0%) underwent IOP-lowering glaucoma laser surgery. Intravitreal anti-VEGF injections are used to treat some conditions associated with glaucoma, such as macular edema due to CRVO, and the rates of IOP-related events in this trial support monitoring IOP in eyes treated with anti-VEGF therapy for macular edema associated with CRVO or HRVO for up to 60 months. ClinicalTrials.gov Identifier: NCT01969708.
  • Publisher: United States: American Medical Association
  • Language: English
  • Identifier: ISSN: 2168-6165
    EISSN: 2168-6173
    EISSN: 1538-3601
    DOI: 10.1001/jamaophthalmol.2021.4395
    PMID: 34709363
  • Source: MEDLINE
    Alma/SFX Local Collection
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