Two-Year Efficacy of Ranibizumab Plus Laser-Induced Chorioretinal Anastomosis vs Ranibizumab Monotherapy for Central Retinal Vein Occlusion

Autor: Ian L. McAllister, Fred K. Chen, David A. Mackey, Lynne A. Smithies, Paul G. Sanfilippo
Rok vydání: 2018
Předmět:
Male
Vascular Endothelial Growth Factor A
medicine.medical_specialty
Time Factors
Visual acuity
genetic structures
Fundus Oculi
medicine.medical_treatment
Visual Acuity
Angiogenesis Inhibitors
Vitrectomy
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Central retinal vein occlusion
law
Ranibizumab
Ophthalmology
Retinal Vein Occlusion
medicine
Humans
Prospective Studies
030212 general & internal medicine
Fluorescein Angiography
Macular edema
Aged
Choroid
Random assignment
business.industry
Anastomosis
Surgical
Retinal Vessels
medicine.disease
eye diseases
Treatment Outcome
Intravitreal Injections
Vitreous hemorrhage
030221 ophthalmology & optometry
Female
Laser Therapy
medicine.symptom
business
Tomography
Optical Coherence
Follow-Up Studies
medicine.drug
Zdroj: JAMA Ophthalmology. 136:1391
ISSN: 2168-6165
DOI: 10.1001/jamaophthalmol.2018.4973
Popis: Adding a laser-induced chorioretinal anastomosis (L-CRA) to current treatments for central retinal vein occlusion (CRVO) may improve outcomes and lessen therapy burdens.To determine the 2-year efficacy of intravitreal ranibizumab with an L-CRA vs ranibizumab alone for patients with macular edema caused by CRVO.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.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.Mean number of injections from month 7 to month 24, change in BCVA, and change in central subfield thickness (CST).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.For macular edema caused by CRVO, an L-CRA significantly reduced the number of ranibizumab injections required.anzctr.org.au Identifier: ACTRN12612000004864.
Databáze: OpenAIRE
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