Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy–Related Macular Edema: 1-Year Outcomes

RRR Study Group

Research output: Contribution to journalArticle

Abstract

Purpose: To assess efficacy of intravitreal ranibizumab injections and targeted panretinal photocoagulation (TRP) for radiation retinopathy–related macular edema. Design: Phase IIb, prospective, randomized clinical trial. Methods: SETTING: Multicenter. SUBJECTS: Forty eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen equivalent). INTERVENTION: Patients either received intravitreal 0.5 mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP. After week 52, all subjects entered a treat-and-extend protocol for ranibizumab. MAIN OUTCOME MEASURES: Mean Early Treatment Diabetic Maculopathy Study (ETDRS) BCVA change from baseline. Results: Mean patient age was 57 years (range, 22-80 years), ETDRS BCVA was 56.7 letters (20/74 Snellen equivalent), and central macular thickness (CMT) was 423 μm (range, 183-826 μm). Thirty-seven patients completed the month 12 visit (92.5%), at which time the change in mean BCVA was +4.0 letters, −1.9 letters, and +0.9 letters in the monthly, monthly plus laser, and PRN plus laser cohorts, respectively. There was a significant difference in mean BCVA at 1 year among all 3 cohorts (P < .001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. A total of 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters. Conclusions: Ranibizumab may improve vision and anatomy in patients with radiation retinopathy–related macular edema and prevent vision loss through 48 weeks of therapy. Monthly injections were more effective than as-needed approach, and the addition of TRP yielded no therapeutic benefits.

Original languageEnglish (US)
Pages (from-to)165-173
Number of pages9
JournalAmerican Journal of Ophthalmology
Volume216
DOIs
StatePublished - Aug 2020

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors/administration & dosage
  • Combined Modality Therapy
  • Female
  • Humans
  • Intravitreal Injections
  • Laser Coagulation
  • Macular Edema/diagnostic imaging
  • Male
  • Melanoma/radiotherapy
  • Middle Aged
  • Prospective Studies
  • Radiation Injuries/diagnostic imaging
  • Radiotherapy/adverse effects
  • Ranibizumab/administration & dosage
  • Retina/radiation effects
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Uveal Neoplasms/radiotherapy
  • Vascular Endothelial Growth Factor A/antagonists & inhibitors
  • Visual Acuity/physiology
  • Young Adult

ASJC Scopus subject areas

  • Ophthalmology

Fingerprint Dive into the research topics of 'Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy–Related Macular Edema: 1-Year Outcomes'. Together they form a unique fingerprint.

Cite this