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Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema: 24-Month Results of the CRYSTAL Study

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@article{864878094c4844a4a9ffae246b0cef3f,
title = "Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema: 24-Month Results of the CRYSTAL Study",
abstract = "Purpose: To assess the efficacy and safety profile of an individualized, stabilization criteria–driven regimen of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Design: A 24-month, prospective, open-label, single-arm, multicenter study. Participants: A total of 357 patients. Methods: Patients received monthly ranibizumab 0.5 mg injections (minimum, 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg injections were administered if monitoring indicated a loss of VA due to disease activity. The primary outcome results have been published previously. Main secondary outcome measures: Mean change from baseline at months 1 through 24 in best-corrected VA (BCVA) in the overall population and in subgroups categorized according to baseline BCVA, CRVO duration, or presence of macular ischemia. Results: The baseline mean BCVA was 53.0 letters and baseline mean CRVO duration was 8.9 months (median, 2.4 months). The mean (standard deviation) gain in BCVA from baseline with ranibizumab 0.5 mg at month 24 was 12.1 (18.60) letters (P < 0.0001). Best-corrected VA gains at month 24 were similar in patients with or without baseline macular ischemia (mean change, 11.1 and 12.9 letters, respectively). The mean BCVA gain at month 24 was higher in patients with CRVO duration <3 months (13.2 letters) compared with that in those with CRVO duration >9 months (10.5 letters). Patients with lower baseline BCVA had larger mean BCVA gains at month 24 (≤39 letters; 18.5 letters) than those with higher baseline BCVA (40–59/≥60 letters; 13.9/7.2 letters), although the absolute BCVA values at month 24 were higher in patients with higher baseline BCVA. The mean (standard deviation) and median number of ranibizumab injections up to month 23 were 13.1 (6.39) and 15.0 injections, respectively. No new ocular or nonocular safety events were reported. Conclusion: An individualized, stabilization criteria–driven dosing regimen of ranibizumab 0.5 mg led to sustained BCVA gains for up to 24 months in patients with CRVO. The presence of macular ischemia at baseline did not influence VA gains. Shorter duration of CRVO at baseline was associated with better VA gains. Safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.",
author = "Michael Larsen and Waldstein, {Sebastian M.} and Siegfried Priglinger and Philip Hykin and Elizabeth Barnes and Margarita Gekkieva and {Das Gupta}, Ayan and Andreas Wenzel and Jordi Mon{\'e}s and {CRYSTAL Study Group}",
year = "2018",
month = feb,
day = "1",
doi = "10.1016/j.oret.2017.05.016",
language = "English",
volume = "2",
pages = "134--142",
journal = "Ophthalmology Retina",
issn = "2468-7219",
publisher = "Elsevier Inc.",
number = "2",

}

RIS

TY - JOUR

T1 - Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema

T2 - 24-Month Results of the CRYSTAL Study

AU - Larsen, Michael

AU - Waldstein, Sebastian M.

AU - Priglinger, Siegfried

AU - Hykin, Philip

AU - Barnes, Elizabeth

AU - Gekkieva, Margarita

AU - Das Gupta, Ayan

AU - Wenzel, Andreas

AU - Monés, Jordi

AU - CRYSTAL Study Group

PY - 2018/2/1

Y1 - 2018/2/1

N2 - Purpose: To assess the efficacy and safety profile of an individualized, stabilization criteria–driven regimen of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Design: A 24-month, prospective, open-label, single-arm, multicenter study. Participants: A total of 357 patients. Methods: Patients received monthly ranibizumab 0.5 mg injections (minimum, 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg injections were administered if monitoring indicated a loss of VA due to disease activity. The primary outcome results have been published previously. Main secondary outcome measures: Mean change from baseline at months 1 through 24 in best-corrected VA (BCVA) in the overall population and in subgroups categorized according to baseline BCVA, CRVO duration, or presence of macular ischemia. Results: The baseline mean BCVA was 53.0 letters and baseline mean CRVO duration was 8.9 months (median, 2.4 months). The mean (standard deviation) gain in BCVA from baseline with ranibizumab 0.5 mg at month 24 was 12.1 (18.60) letters (P < 0.0001). Best-corrected VA gains at month 24 were similar in patients with or without baseline macular ischemia (mean change, 11.1 and 12.9 letters, respectively). The mean BCVA gain at month 24 was higher in patients with CRVO duration <3 months (13.2 letters) compared with that in those with CRVO duration >9 months (10.5 letters). Patients with lower baseline BCVA had larger mean BCVA gains at month 24 (≤39 letters; 18.5 letters) than those with higher baseline BCVA (40–59/≥60 letters; 13.9/7.2 letters), although the absolute BCVA values at month 24 were higher in patients with higher baseline BCVA. The mean (standard deviation) and median number of ranibizumab injections up to month 23 were 13.1 (6.39) and 15.0 injections, respectively. No new ocular or nonocular safety events were reported. Conclusion: An individualized, stabilization criteria–driven dosing regimen of ranibizumab 0.5 mg led to sustained BCVA gains for up to 24 months in patients with CRVO. The presence of macular ischemia at baseline did not influence VA gains. Shorter duration of CRVO at baseline was associated with better VA gains. Safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.

AB - Purpose: To assess the efficacy and safety profile of an individualized, stabilization criteria–driven regimen of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Design: A 24-month, prospective, open-label, single-arm, multicenter study. Participants: A total of 357 patients. Methods: Patients received monthly ranibizumab 0.5 mg injections (minimum, 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg injections were administered if monitoring indicated a loss of VA due to disease activity. The primary outcome results have been published previously. Main secondary outcome measures: Mean change from baseline at months 1 through 24 in best-corrected VA (BCVA) in the overall population and in subgroups categorized according to baseline BCVA, CRVO duration, or presence of macular ischemia. Results: The baseline mean BCVA was 53.0 letters and baseline mean CRVO duration was 8.9 months (median, 2.4 months). The mean (standard deviation) gain in BCVA from baseline with ranibizumab 0.5 mg at month 24 was 12.1 (18.60) letters (P < 0.0001). Best-corrected VA gains at month 24 were similar in patients with or without baseline macular ischemia (mean change, 11.1 and 12.9 letters, respectively). The mean BCVA gain at month 24 was higher in patients with CRVO duration <3 months (13.2 letters) compared with that in those with CRVO duration >9 months (10.5 letters). Patients with lower baseline BCVA had larger mean BCVA gains at month 24 (≤39 letters; 18.5 letters) than those with higher baseline BCVA (40–59/≥60 letters; 13.9/7.2 letters), although the absolute BCVA values at month 24 were higher in patients with higher baseline BCVA. The mean (standard deviation) and median number of ranibizumab injections up to month 23 were 13.1 (6.39) and 15.0 injections, respectively. No new ocular or nonocular safety events were reported. Conclusion: An individualized, stabilization criteria–driven dosing regimen of ranibizumab 0.5 mg led to sustained BCVA gains for up to 24 months in patients with CRVO. The presence of macular ischemia at baseline did not influence VA gains. Shorter duration of CRVO at baseline was associated with better VA gains. Safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.

UR - http://www.scopus.com/inward/record.url?scp=85045729133&partnerID=8YFLogxK

U2 - 10.1016/j.oret.2017.05.016

DO - 10.1016/j.oret.2017.05.016

M3 - Journal article

AN - SCOPUS:85045729133

VL - 2

SP - 134

EP - 142

JO - Ophthalmology Retina

JF - Ophthalmology Retina

SN - 2468-7219

IS - 2

ER -

ID: 59451564