Abstract | IMPORTANCE: OBJECTIVE: DESIGN: Phase 3, double-masked, randomized, multicenter clinical trial. Data reported were collected from June 2010 to March 2012 and include 16 weeks of follow-up. SETTING: Community-based and academic-based ophthalmology practices specializing in retinal diseases. PARTICIPANTS: INTERVENTION: Eyes were randomly assigned to 0.5-mg intravitreal ranibizumab (n = 125) or intravitreal saline (n = 136) at baseline and 4 and 8 weeks. MAIN OUTCOME MEASURE: Cumulative probability of vitrectomy within 16 weeks. RESULTS: Cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab vs 17% with saline (difference, 4%; 95% CI, -4% to 13%) and of complete panretinal photocoagulation without vitrectomy by 16 weeks was 44% and 31%, respectively (P = .05). The mean (SD) visual acuity improvement from baseline to 12 weeks was 22 (23) letters and 16 (31) letters, respectively (P = .04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17%, respectively (P = .01). One eye developed endophthalmitis after saline injection. CONCLUSIONS AND RELEVANCE: Overall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR. Short-term secondary outcomes including visual acuity improvement, increased panretinal photocoagulation completion rates, and reduced recurrent vitreous hemorrhage rates suggest biologic activity of ranibizumab. Long-term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab injection are different than observation alone cannot be determined from this study. TRIAL REGISTRATION: The study is listed on www.clinicaltrials.gov, under identifier NCT00996437 (website registration date October 14, 2009).
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Authors | Diabetic Retinopathy Clinical Research Network* |
Journal | JAMA ophthalmology
(JAMA Ophthalmol)
Vol. 131
Issue 3
Pg. 283-93
(Mar 2013)
ISSN: 2168-6173 [Electronic] United States |
PMID | 23370902
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal, Humanized
- Sodium Chloride
- Ranibizumab
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Topics |
- Aged
- Angiogenesis Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
(administration & dosage, adverse effects, therapeutic use)
- Diabetes Mellitus, Type 1
(complications)
- Diabetes Mellitus, Type 2
(complications)
- Diabetic Retinopathy
(complications)
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Intravitreal Injections
- Male
- Middle Aged
- Ranibizumab
- Recurrence
- Retinal Neovascularization
(complications)
- Sodium Chloride
(therapeutic use)
- Tomography, Optical Coherence
- Treatment Outcome
- Vision Disorders
(drug therapy, etiology, physiopathology)
- Visual Acuity
(physiology)
- Vitrectomy
(statistics & numerical data)
- Vitreous Hemorrhage
(drug therapy, etiology)
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