Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial

the RRR Study Group

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

PURPOSE: To assess the efficacy of a treat-and-extend strategy with intravitreal ranibizumab for radiation-related macular edema.

METHODS: Forty eyes with radiation-induced macular edema and decreased visual acuity were enrolled in the phase IIb, prospective clinical trial and randomized into 3 cohorts: (A) monthly ranibizumab, (B) monthly ranibizumab with targeted retinal photocoagulation (TRP), or (C) as-needed ranibizumab and TRP. In year 2, all subjects entered a treat-and-extend protocol for ranibizumab. The primary outcome measure was mean change in early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) from baseline.

RESULTS: Through year 1, the mean change in ETDRS BCVA was significantly different between the three cohorts (p < 0.001); cohort A saw the largest gain with + 4.0 letters. Significant anatomic improvements were also seen in all cohorts. Comparatively, through year 2, cohorts A, B, and C had a mean change in ETDRS BCVA of - 1.9, - 3.9, and + 1.3 letters, respectively; additionally, no significant differences were found in absolute ETDRS BCVA across time (ANOVA, p = 0.123). Overall, 90% of eyes maintained VA 20/200 or better and 33.3% of subjects gained at least one line of vision. There were no significant differences in mean central macular thickness for any cohort compared to baseline (p = 0.09). The presence of retinal hemorrhage and intraretinal exudates stayed consistent from year 1 to year 2 for all cohorts.

CONCLUSIONS: Among eyes with radiation-related macular edema, a treat-and-extend regimen with ranibizumab may not result in as many visual and anatomic improvements as monthly injections. However, treat-and-extend still may prevent serious visual complications compared to historical controls.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02222610.

Original languageEnglish (US)
Pages (from-to)47-54
Number of pages8
JournalGraefe's Archive for Clinical and Experimental Ophthalmology
Volume260
Issue number1
DOIs
StatePublished - Jan 2022

Keywords

  • Anti-vascular endothelial growth factor
  • Brachytherapy
  • Macular edema
  • Radiation retinopathy
  • Targeted retinal photocoagulation
  • Uveal melanoma
  • Vascular Endothelial Growth Factor A
  • Prospective Studies
  • Intravitreal Injections
  • Tomography, Optical Coherence
  • Humans
  • Macular Edema/diagnosis
  • Treatment Outcome
  • Laser Coagulation
  • Visual Acuity
  • Angiogenesis Inhibitors/therapeutic use
  • Ranibizumab/therapeutic use

ASJC Scopus subject areas

  • Sensory Systems
  • Cellular and Molecular Neuroscience
  • Ophthalmology

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