Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial

Autor: Hani Salehi-Had, Omar S. Punjabi, Neil M. Bressler, Lee M. Jampol, Danni Liu, Jennifer K. Sun, Adam R. Glassman, Michele Melia, Roy W. Beck, Abdhish R. Bhavsar, Raj K. Maturi
Rok vydání: 2017
Předmět:
0301 basic medicine
Male
Vascular Endothelial Growth Factor A
medicine.medical_specialty
Intraocular pressure
Visual acuity
Randomization
genetic structures
Visual Acuity
Angiogenesis Inhibitors
Dexamethasone
Macular Edema
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Interquartile range
law
Ophthalmology
Ranibizumab
medicine
Humans
Macula Lutea
Glucocorticoids
Aged
Retrospective Studies
Original Investigation
Intention-to-treat analysis
Diabetic Retinopathy
Dose-Response Relationship
Drug
business.industry
Diabetic retinopathy
Middle Aged
medicine.disease
eye diseases
Surgery
030104 developmental biology
Intravitreal Injections
030221 ophthalmology & optometry
Drug Therapy
Combination
Female
medicine.symptom
business
Tomography
Optical Coherence
medicine.drug
Follow-Up Studies
Zdroj: JAMA ophthalmology. 136(1)
ISSN: 2168-6173
0194-5866
Popis: Some eyes have persistent diabetic macular edema (DME) following anti-vascular endothelial growth factor (anti-VEGF) therapy for DME. Subsequently adding intravitreous corticosteroids to the treatment regimen might result in better outcomes than continued anti-VEGF therapy alone.To compare continued intravitreous ranibizumab alone with ranibizumab plus intravitreous dexamethasone implant in eyes with persistent DME.Phase 2 multicenter randomized clinical trial conducted at 40 US sites in 129 eyes from 116 adults with diabetes between February 2014 and December 2016. Eyes had persistent DME, with visual acuity of 20/32 to 20/320 after at least 3 anti-VEGF injections before a run-in phase, which included an additional 3 monthly 0.3-mg ranibizumab injections. Data analysis was according to intent to treat.Following the run-in phase, study eyes that had persistent DME and were otherwise eligible were randomly assigned to receive 700 μg of dexamethasone (combination group, 65 eyes) or sham treatment (ranibizumab group, 64 eyes) in addition to continued 0.3-mg ranibizumab in both treatment arms as often as every 4 weeks based on a structured re-treatment protocol.The primary outcome was change in mean visual acuity letter score at 24 weeks as measured by the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS). The principal secondary outcome was change in mean central subfield thickness as measured with the use of optical coherence tomography.Of the 116 randomized patients, median age was 65 years (interquartile range [IQR], 58-71 years); 50.9% were female and 60.3% were white. Mean (SD) improvement in visual acuity from randomization was 2.7 (9.8) letters in the combination group and 3.0 (7.1) letters in the ranibizumab group, with the adjusted treatment group difference (combination minus ranibizumab) of -0.5 letters (95% CI, -3.6 to 2.5; 2-sided P = .73). Mean (SD) change in central subfield thickness in the combination group was -110 (86) μm compared with -62 (97) μm for the ranibizumab group (adjusted difference, -52; 95% CI, -82 to -22; 2-sided P .001). Nineteen eyes (29%) in the combination group experienced increased intraocular pressure or initiated treatment with antihypertensive eyedrops compared with 0 in the ranibizumab group (2-sided P .001).Although its use is more likely to reduce retinal thickness and increase intraocular pressure, the addition of intravitreous dexamethasone to continued ranibizumab therapy does not improve visual acuity at 24 weeks more than continued ranibizumab therapy alone among eyes with persistent DME following anti-VEGF therapy.clinicaltrials.gov Identifier: NCT01945866.
Databáze: OpenAIRE
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