Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration

Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3.

Abstract

Summary statement: Intravitreal high dose (2 mg) ranibizumab may lead to quicker resolution of choroidal neovascularization (CNV) and associated retinal pigment epithelial detachment in eyes with exudative age-related macular degeneration, although it may possibly correlate with RPE tears in certain cases.

Purpose: This prospective study compared the outcomes of 0.5 vs 2.0 mg intravitreal ranibizumab injections (RI) for treating vascularized pigment epithelial detachment (vPED) due to age-related macular degeneration.

Methods: Patients with vPED were randomized to receive 2.0 vs 0.5 mg RI monthly for 12 months or for 4 months and then repeated on a pro-re nata basis. Optical coherence tomography, fundus photography, and fluorescein and indocyanine-green angiography were obtained at baseline and subsequent specific intervals. Outcome measures were best-corrected standardized visual acuities, central 1-mm thickness, surface area (SA), greatest linear diameter (GLD), heights (PED and CNV), and amount of subretinal fluid (SRF) and cystoid macular edema (CME).

Results: Both groups yielded reductions of the central 1-mm thickness, PED and CNV SA and PED height and GLD, SRF, and CME. Vision improvement and reduction in SRF and PED height occurred earlier for eyes receiving the 2.0 mg dose. Cataract progression was similar but RPE tears developed more often with the 2.0 mg dose.

Conclusions: There were similar visual and anatomical outcomes at the end of the study; however, the higher dose yielded more rapid reductions and more complete resolution of the PED, although there was possible increased tendency for an RPE tear with the higher dose.

Trial registration: ClinicalTrials.gov NCT00749021.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / administration & dosage*
  • Angiogenesis Inhibitors / adverse effects
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Coloring Agents
  • Contrast Sensitivity
  • Female
  • Fluorescein Angiography
  • Humans
  • Indocyanine Green
  • Intravitreal Injections
  • Male
  • Prospective Studies
  • Ranibizumab
  • Retinal Detachment / diagnosis
  • Retinal Detachment / drug therapy*
  • Retinal Detachment / physiopathology
  • Retinal Neovascularization / diagnosis
  • Retinal Neovascularization / drug therapy*
  • Retinal Neovascularization / physiopathology
  • Retinal Pigment Epithelium / blood supply*
  • Risk Assessment
  • Sickness Impact Profile
  • Tomography, Optical Coherence
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity / physiology
  • Wet Macular Degeneration / diagnosis
  • Wet Macular Degeneration / drug therapy*
  • Wet Macular Degeneration / physiopathology

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Coloring Agents
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Indocyanine Green
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00749021