Abstract
Background/objectivesThis post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).Subjects/methodsEyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.ResultsOedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).ConclusionsMacular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.
Highlights
Intravitreal vascular endothelial growth factor-A antagonists are currently regarded as appropriate first-line therapy for most patients with centre-involved diabetic macular oedema (DMO), resulting in visual acuity loss [1]
Given that the use of anti-VEGF treatment in clinical practice is based in large part on optical coherence tomography changes, the present analysis explores the anatomic–functional relationship further by assessing macular thickness over the course of ranibizumab treatment rather than at a single time point
Persistence of macular oedema into the second year of ranibizumab treatment Persistence of macular oedema into the second year of ranibizumab treatment was assessed in terms of 1) the cumulative number of study visits with central subfield retinal thickness (CRT) ≥250 μm during weeks 52–104, and 2) the average amount of oedema (CRT ≥250 μm) during weeks 52–104
Summary
Intravitreal vascular endothelial growth factor-A antagonists (anti-VEGF agents) are currently regarded as appropriate first-line therapy for most patients with centre-involved diabetic macular oedema (DMO), resulting in visual acuity loss [1]. Randomised clinical trials indicate that these agents are more effective than laser photocoagulation in reducing macular thickness and improving visual acuity in eyes with centre-involved DMO [2,3,4]. A post hoc analysis indicating relatively limited visual acuity improvement in eyes receiving deferred as opposed to prompt ranibizumab treatment in the RISE and RIDE clinical trials suggests that chronic macular oedema might reduce the capacity for vision gain in DMO [20]. The published literature is, inconsistent regarding the relationship between the anatomic and functional responses to laser photocoagulation [27], corticosteroid [14] and anti-VEGF [18, 28, 29] therapy in DMO
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