Purpose: Our primary purpose was to assess the clinical (predictive) validity of central retinal thickness (CRT) and best corrected visual acuity (BCVA) at 1 week and 1 month after starting treatment with ranibizumab for central retinal vein occlusion. The authors also assessed detectability of response to treatment.Methods: The authors used data from 325 participants in the CRUISE study, which included measurement of time-domain CRT and BCVA at baseline, 1 week, 1 month, and 6 months postrandomization. Analysis of covariance models were fitted to assess clinical validity, and distributions of change were constructed to assess detectability of response.Results: There was no evidence that 1-week CRT, and very strong evidence that 1-week BCVA were associated with baseline-adjusted BCVA at 6 months (P = 0.17 and P < 0.001, respectively). There was strong evidence that both 1-month CRT and 1-month BCVA were associated with baseline-adjusted 6-month BCVA (P = 0.005 and P < 0.001, respectively), but simultaneous adjustment found evidence of independent association only for BCVA (P = 0.71 and P < 0.001 for CRT and BCVA, respectively). Detectability of response tended to be higher for CRT than BCVA at 1 week and 1 month but by 6 months these were equivalent for CRT and BCVA.Conclusion: In this study, BCVA monitoring of treated central retinal vein occlusion patients seemed more informative than time-domain optical coherence tomography monitoring.

The aim of this study was to assess the impact of baseline characteristics on visual outcome of patients with diabetic macular edema and compare the results of clinical trials with different patient populations.

Aim: To review and compare methods for indirect comparison of aflibercept and ranibizumab in patients with diabetic macular edema.Methods: Post-stratification, inverse probability weighting based on simulated data, weight optimization, and regression model techniques were used to compare pooled individual patient-level data from the RESTORE and RESPOND (ranibizumab 0.5mg as needed after 3 initial monthly doses) studies with summary-level data from the VIVID and VISTA (aflibercept 2.0 mg every 8 weeks after 5 initial monthly doses, 2q8) studies. The impact of adjusting for up to two baseline characteristics was assessed.Results: All methods provided similar results. After adjustment for baseline best-corrected visual acuity and central retinal thickness, no statistically significant difference in average gain in baseline best-corrected visual acuity from baseline at month 12 was found between ranibizumab 0.5mg and aflibercept 2q8.Conclusions: Weight optimization and regression methods are useful options to adjust for more than one baseline characteristic.

PURPOSE:To establish the predictive value of defined retinal morphologic parameters on visual outcomes and re-treatment needs in patients with neovascular age-related macular degeneration (nAMD) receiving ranibizumab treatment.DESIGN:Post hoc analysis of a prospective, 12-month, multicenter, phase IIIb trial.PARTICIPANTS:Three hundred fifty-three treatment-naïve patients with nAMD.METHODS:Available data from 319 treatment-naïve patients receiving ranibizumab 0.3 mg monthly (frequent regimen; n = 102) or ranibizumab 0.3 or 0.5 mg quarterly (pooled 0.3/0.5 mg = infrequent regimen; n = 217) were analyzed to assess the correlations between baseline retinal morphologic parameters and best-corrected visual acuity (BCVA) change (structure-function correlations). The BCVA was measured at monthly visits. Optical coherence tomography scans were acquired monthly for quantitative measures of the central retinal thickness and qualitative assessment of retinal morphologic features. Assessed morphologic parameters included intraretinal cystoid fluid (IRC), subretinal fluid (SRF), pigment epithelial detachment, and vitreomacular interface configuration classification comprising vitreomacular adhesion and posterior vitreous detachment (PVD). An analysis of covariance was conducted to evaluate the impact of retinal morphologic features on BCVA change at month 12.MAIN OUTCOME MEASURES:Change in BCVA from baseline to month 12 compared between frequent and infrequent treatment arms.RESULTS:Relevant predictive factors for BCVA change at month 12 were baseline SRF (P = 0.05), PVD (P = 0.03), IRC (P = 0.05), treatment frequency (P < 0.01), and BCVA (P < 0.01). The presence of both SRF and PVD at baseline was associated with similar BCVA gains regardless of treatment frequency (mean difference in BCVA gains at month 12 of +2.6 letters in favor of infrequent treatment). Subretinal fluid was present in 71% of patients, and PVD was present in 64% of patients.CONCLUSIONS:In patients with both SRF and PVD at baseline, similar BCVA outcomes were observed regardless of treatment frequency. These patients may require less frequent treatments compared with patients without SRF, without PVD, or without either who may require more frequent injections for maintenance of vision. This finding may have implications in clinical practice by helping to tailor an individualized re-treatment interval in nAMD patients.

Early CRT monitoring using time-domain optical coherence tomography does not add to visual acuity for predicting visual loss in patients with central retinal vein occlusion treated with intravitreal ranibizumab A secondary analysis of trial data Bell, Katy J L; Hayen, Andrew; Glasziou, Paul; Mitchell, Andrew S.; Farris, Maria; Wright, Jonathan; Duerr, Hans Peter; Mitchell, Paul; Irwig, Les Published in: Retina