Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration: TREX-AMD 1-Year Results.
Ophthalmology
; 122(12): 2514-22, 2015 Dec.
Article
em En
| MEDLINE
| ID: mdl-26391465
ABSTRACT
PURPOSE:
To assess prospectively a treat-and-extend (TREX) management strategy compared with monthly dosing of intravitreal ranibizumab in treatment-naïve neovascular age-related macular degeneration (AMD) patients.DESIGN:
Phase IIIb, multicenter, randomized, controlled clinical trial.PARTICIPANTS:
Sixty patients with treatment-naïve neovascular AMD randomized 12 to monthly or TREX management.METHODS:
Patients with Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) from 20/32 to 20/500 (Snellen equivalent) were randomized to receive intravitreal 0.5 mg ranibizumab monthly or according to a TREX protocol. The TREX patients were treated monthly for at least 3 doses, until resolution of clinical and spectral-domain optical coherence tomography evidence of exudative disease activity; the interval between visits then was individualized according to a strict prospective protocol. MAIN OUTCOMEMEASURES:
Mean ETDRS BCVA change from baseline.RESULTS:
At baseline, mean age was 77 years (range, 59-96 years), mean BCVA was 20/60 (Snellen equivalent), and mean central retinal thickness (CRT) was 511 µm. Fifty-seven eyes (95%) completed month 12, at which point mean BCVA improved by 9.2 and 10.5 letters in the monthly and TREX cohorts, respectively (P = 0.60). The mean number of injections administered through month 12 was 13.0 and 10.1 (range, 7-13) in the monthly and TREX cohorts, respectively (P < 0.0001). Among TREX patients, 7 (18%) were maximally extended, 4 (10%) demonstrated fluid at every visit, and at month 12, 18 (45%) had achieved an extension interval of 8 weeks or more; the mean maximum extension interval between injections after the first 3 monthly doses was 8.4 weeks (range, 4-12 weeks). Most TREX patients who demonstrated recurrent exudative disease activity (17/24 [71%]) were unable to extend beyond their initial maximum extension interval.CONCLUSIONS:
The TREX neovascular AMD management strategy used in this prospective, randomized, controlled trial resulted in visual and anatomic gains comparable with those obtained with monthly dosing.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Inibidores da Angiogênese
/
Degeneração Macular Exsudativa
/
Ranibizumab
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Guideline
/
Observational_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Ophthalmology
Ano de publicação:
2015
Tipo de documento:
Article