Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study

I. Pearce, S. Banerjee, B.J.L. Burton, U. Chakravarthy, L. Downey, R.P. Gale, J. Gibson, S. Pagliarini, J. Patel, S. Sivaprasad, C. Andrews, C. Brittain, J. Warburton

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32 Citations (Scopus)

Abstract

Purpose To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema (DME). Design A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom. Participants Participants (N = 109) with visual impairment due to DME. Methods Participants received 3 initial monthly ranibizumab 0.5 mg injections (day 0 to month 2), followed by individualized best-corrected visual acuity (BCVA) and optical coherence tomography-guided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6. Main Outcome Measures Mean change in BCVA from baseline to month 12 (primary end point), mean change in BCVA and central retinal thickness (CRT) from baseline to month 18, gain of ≥10 and ≥15 letters, treatment exposure, and incidence of adverse events over 18 months. Results Of 109 participants, 100 (91.7%) and 99 (90.8%) completed the 12 and 18 months of the study, respectively. The mean age was 63.7 years, the mean duration of DME was 40 months, and 77.1% of the participants had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of patients had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1 μm, with 32% of patients having a baseline CRT
Original languageEnglish
Pages (from-to)1811-1819
Number of pages9
JournalOphthalmology
Volume122
Issue number9
DOIs
Publication statusPublished - 2015

Bibliographical note

cited By 18

Keywords

  • ranibizumab
  • angiogenesis inhibitor
  • monoclonal antibody
  • vasculotropin A
  • VEGFA protein, human, abnormal sensation
  • adult
  • Article
  • best corrected visual acuity
  • blurred vision
  • cataract
  • central retinal thickness
  • conjunctival hemorrhage
  • coughing
  • diabetic macular edema
  • drug efficacy
  • drug eruption
  • drug screening
  • dry eye
  • endophthalmitis
  • female
  • foreign body sensation
  • human
  • hypoglycemia
  • incidence
  • laser safety
  • loading drug dose
  • low level laser therapy
  • lower respiratory tract infection
  • macular edema
  • major clinical study
  • male
  • multicenter study
  • non insulin dependent diabetes mellitus
  • open study
  • optical coherence tomography
  • patient monitoring
  • phase 3 clinical trial
  • priority journal
  • prospective study
  • rhinopharyngitis
  • risk assessment
  • side effect
  • spectral domain optical coherence tomography
  • transient ischemic attack
  • United Kingdom
  • urinary tract infection
  • visual acuity
  • visual impairment
  • vitreous hemorrhage
  • aged
  • antagonists and inhibitors
  • clinical trial
  • controlled study
  • diabetic retinopathy
  • drug effects
  • drug monitoring
  • intravitreal drug administration
  • middle aged
  • pathophysiology
  • physiology
  • randomized controlled trial
  • retreatment, Aged
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Diabetic Retinopathy
  • Drug Monitoring
  • Female
  • Humans
  • Intravitreal Injections
  • Macular Edema
  • Male
  • Middle Aged
  • Prospective Studies
  • Retreatment
  • Tomography, Optical Coherence
  • Vascular Endothelial Growth Factor A
  • Visual Acuity

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