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Ophthalmology. 2016 May;123(5):1101-11. doi: 10.1016/j.ophtha.2016.01.011. Epub 2016 Feb 17.

Individualized Ranibizumab Regimen Driven by Stabilization Criteria for Central Retinal Vein Occlusion: Twelve-Month Results of the CRYSTAL Study.

Author information

  • 1Department of Ophthalmology, Rigshospitalet, and Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: miclar01@regionh.dk.
  • 2Department of Ophthalmology, Vienna Reading Center, Medical University of Vienna, Vienna, Austria.
  • 3The Eye Clinic, University of Sassari, Sassari, Italy.
  • 4Department of Retinology, Klinik Pallas, Olten, Switzerland, and Department of Ophthalmology, University of Münster, Münster, Germany.
  • 5Institut de la Màcula, Centro Médico Teknon, and Barcelona Macula Foundation, Barcelona, Spain.
  • 6Department of Ophthalmology, Hôpital Lariboisière, AP-HP, Université Paris 7-Sorbonne Paris Cité, Paris, France.
  • 7Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.
  • 8Novartis Pharma AG, Basel, Switzerland.
  • 9St. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.

Abstract

PURPOSE:

To assess the 12-month efficacy and safety profile of an individualized regimen of ranibizumab 0.5 mg driven by stabilization criteria in patients with macular edema secondary to central retinal vein occlusion (CRVO).

DESIGN:

A 24-month, prospective, open-label, single-arm, multicenter study.

PARTICIPANTS:

Three hundred fifty-seven patients.

METHODS:

Patients were treated with monthly ranibizumab 0.5-mg injections (minimum of 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg was dosed as needed if monthly monitoring indicated a loss of VA resulting from disease activity.

MAIN OUTCOME MEASURES:

Mean change from baseline at month 12 in best-corrected VA (BCVA; primary end point) and safety over 12 months. The efficacy of this regimen in subgroups categorized by baseline BCVA score, CRVO duration, or presence of macular ischemia (exploratory analysis).

RESULTS:

At baseline, the mean BCVA was 53.0 letters and mean CRVO duration was 8.9 months (median, 2.4 months). Ranibizumab 0.5-mg treatment resulted in a statistically significant mean gain in BCVA from baseline at month 12 of 12.3 letters (standard deviation [SD], 16.72 letters; P < 0.0001). The mean number of ranibizumab injections up to month 12 was 8.1 (SD, 2.77). At month 12, mean BCVA gains were similar with or without macular ischemia at baseline (11.6 vs. 12.1 letters); the mean BCVA gain was higher with baseline CRVO duration of less than 3 months (13.4 letters) than with a longer duration (≥3-<9 months, 11.1 letters; ≥9 months, 10.9 letters). Patients with lower baseline BCVA had larger mean BCVA gains at month 12 than those with higher baseline BCVA (≤39/40-59/≥60 and 18.0/12.7/8.9 letters, respectively), although the absolute BCVA at month 12 was higher with higher baseline BCVA. No new ocular or nonocular safety events were observed.

CONCLUSIONS:

An individualized dosing regimen of ranibizumab 0.5 mg driven by stabilization criteria for up to 12 months resulted in significant BCVA gain in a broad population of patients with macular edema secondary to CRVO, including those with macular ischemia at baseline. The safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.

PMID:
26896124
DOI:
10.1016/j.ophtha.2016.01.011
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