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Original Investigation
December 2018

Two-Year Efficacy of Ranibizumab Plus Laser-Induced Chorioretinal Anastomosis vs Ranibizumab Monotherapy for Central Retinal Vein Occlusion: A Randomized Clinical Trial

Author Affiliations
  • 1Centre for Ophthalmology and Visual Science, Lions Eye Institute, University of Western Australia, Perth, Western Australia, Australia
  • 2Department of Ophthalmology, Royal Perth Hospital, Perth, Western Australia, Australia
  • 3Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Melbourne, Victoria, Australia
JAMA Ophthalmol. 2018;136(12):1391-1397. doi:10.1001/jamaophthalmol.2018.4973
Key Points

Question  Does the addition of a laser-induced chorioretinal anastomosis (L-CRA) to intravitreal ranibizumab treatment for a central retinal vein occlusion modify outcomes?

Findings  In this randomized clinical trial including 58 participants randomized to receive L-CRA plus intravitreal ranibizumab injections or a sham procedure plus intravitreal ranibizumab injections, the addition of an L-CRA significantly reduced the number of ranibizumab injections required in the follow-up period from 7 months to 2 years. The intervention group had better visual acuity at 2 years.

Meaning  These results suggest that the inclusion of an L-CRA to current intravitreal treatment for central retinal vein occlusion can reduce the number of injections required and lessen the burden of therapy.

Abstract

Importance  Adding a laser-induced chorioretinal anastomosis (L-CRA) to current treatments for central retinal vein occlusion (CRVO) may improve outcomes and lessen therapy burdens.

Objective  To determine the 2-year efficacy of intravitreal ranibizumab with an L-CRA vs ranibizumab alone for patients with macular edema caused by CRVO.

Design, Setting, and Participants  In this randomized clinical trial conducted at a single university clinic from March 2012 to June 2015, 58 participants with macular edema caused by CRVO were randomized 1:1 to either an L-CRA or sham procedure at baseline. All participants received monthly intravitreal injections of ranibizumab, 0.5 mg. Data were analyzed from April 2017 to September 2017.

Interventions  Random assignment to L-CRA plus monthly injections of intravitreal ranibizumab, 0.5 mg, (combination group; n = 29) or to a sham L-CRA procedure plus monthly injections of intravitreal ranibizumab, 0.5 mg, (ranibizumab alone group; n = 29) for 6 months. From month 7 to month 24, participants were evaluated monthly and received an injection of ranibizumab if a loss of 5 or more letters of best-corrected visual acuity (BCVA) on ETDRS chart from previous highest score occurred or if there was evidence of residual macular edema on optical coherence tomography.

Main Outcomes and Measures  Mean number of injections from month 7 to month 24, change in BCVA, and change in central subfield thickness (CST).

Results  Of the 58 included participants, 38 (66%) were men, and the mean (SD) age was 68.6 (11.8) years; participants had a mean (SD) BCVA of 57.09 (11.87) ETDRS letters (Snellen equivalent, 20/73) and a mean (SD) CST of 738.36 (175.54) μm. A successful L-CRA was created in 24 of 29 participants (83%) in the combination group. The mean number of injections from month 7 to month 24 was 3.2 (95% CI, 2.5-3.8) in the combination group and 7.1 (95% CI, 6.0-8.0) in the ranibizumab alone group. The ratio of the number of injections in the combination group compared with the ranibizumab alone group was 0.46 (95% CI, 0.36-0.61; P < .001). Mixed-effects regression modeling showed a difference in mean BCVA at 2 years between the combination and ranibizumab alone groups (combination, 70.3 letters [Snellen equivalent, 20/40]; ranibizumab alone, 61.6 letters [Snellen equivalent, 20/60]; difference, 8.8 letters; 95% CI, 0.2-17.3; P = .05). There was also a difference in CST at 2 years between the combination and ranibizumab alone groups (mean CST: combination, 303.6 μm; ranibizumab alone, 394.5 μm; difference, 90.9 μm; 95% CI, 24.3-157.5; P = .01). Four participants (14%) in the combination group required a vitrectomy for early macular traction or vitreous hemorrhage.

Conclusions and Relevance  For macular edema caused by CRVO, an L-CRA significantly reduced the number of ranibizumab injections required.

Trial Registration  anzctr.org.au Identifier: ACTRN12612000004864

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