Expanded 2-Year Follow-up of Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema

• Published in: Ophthalmology (Rochester, Minn.) Vol. 118; no. 4; pp. 609 - 614
• Main Authors: Elman, Michael J., MD, Bressler, Neil M., MD, Qin, Haijing, MS, Beck, Roy W., MD, PhD, Ferris, Frederick L., MD, Friedman, Scott M., MD, Glassman, Adam R., MS, Scott, Ingrid U., MD, MPH, Stockdale, Cynthia R., MSPH, Sun, Jennifer K., MD, MPH
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-04-2011; Elsevier
• Subjects: Angiogenesis Inhibitors - therapeutic use; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Biological and medical sciences; Combined Modality Therapy; Diabetes. Impaired glucose tolerance; Diabetic Retinopathy - physiopathology; Diabetic Retinopathy - therapy; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; Follow-Up Studies; Glucocorticoids - therapeutic use; Humans; Intravitreal Injections; Laser Coagulation; Macular Edema - physiopathology; Macular Edema - therapy; Male; Medical sciences; Middle Aged; Miscellaneous; Ophthalmology; Ranibizumab; Retina - pathology; Retinopathies; Tomography, Optical Coherence; Triamcinolone Acetonide - therapeutic use; Vascular Endothelial Growth Factor A - antagonists & inhibitors; Visual Acuity - physiology; Endocrinopathy; Corticosteroid; Retinopathy; Diabetes mellitus; Antiinflammatory agent; Retinal edema; Monoclonal antibody; Immunomodulator; Eye disease; Vascular endothelium growth factor; Adrenal hormone; Laser; Ranibizumab; Ophthalmology; Antiangiogenic agent; Triamcinolone; Expansion
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2010.12.033

Objective To report expanded 2-year follow-up of a previously reported randomized trial evaluating intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants A total of 854 study eyes of 691 participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Methods Continuation of procedures previously reported for the randomized trial. Main Outcome Measures Best-corrected visual acuity and safety at the 2-year visit. Results At the 2-year visit, compared with the sham + prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab + prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI], −0.4 to +7.7), 5.8 letters greater in the ranibizumab + deferred laser group (95% aCI, +1.9 to +9.8), and 1.5 letters worse in the triamcinolone + prompt laser group (95% aCI, −5.5 to +2.4). After the 1- to 2-year visit in the ranibizumab + prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab + prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the triamcinolone + prompt laser group. No systemic events attributable to study treatment were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Conclusions The expanded 2-year results reported are similar to results published previously and reinforce the conclusions originally reported: Ranibizumab should be considered for patients with DME and characteristics similar to those of the cohort in this clinical trial, including vision impairment with DME involving the center of the macula. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.