Efficacy of Treatments for Macular Edema Secondary to RVO
Efficacy of Treatments for Macular Edema Secondary to RVO
In conclusion, data from high-quality RCTs for ranibizumab and dexamethasone IVT have demonstrated that both new agents have promising outcomes for the treatment of BRVO and CRVO, and constitute significant improvements over the previously widely accepted standards of care (laser therapy for BRVO and no treatment for CRVO). Significant differences in study design and patient baseline characteristics prevent indirect comparisons being made between these treatments. Ranibizumab and dexamethasone IVT both produce rapid improvements in BCVA. These improvements appear to be maintained with initial monthly therapy followed by treatment as needed for ranibizumab, but decline 3 months after administration of the dexamethasone IVT implant. Dexamethasone IVT is associated with a significantly greater risk of increased IOP (which increased further with repeated treatment) and possibly an increased risk of cataract than is sham.
Head-to-head comparative studies are urgently needed to assess the relative efficacies of available licensed therapies for RVO. This is currently being assessed in three ongoing RCTs comparing ranibizumab with dexamethasone IVT in patients with RVO; the COMO (NCT01427751) and COMRADE B (NCT01396057) studies are being conducted in patients with BRVO and the COMRADE C study (NCT01396083) is being conducted in patients with CRVO. Direct comparison of the licensed therapies with laser monotherapy and the role of adjunctive laser therapy are currently lacking. This issue is being addressed by the RABAMES study (NCT00562406) comparing ranibizumab, laser monotherapy and ranibizumab plus adjunctive laser therapy in patients with BRVO; this study has been completed and data are expected shortly. A further study comparing similar treatment arms, the BRIGHTER study (NCT01599650, EUDRACT 2011–002859–34), has begun recruiting in Europe. Results from these studies should help to clarify the roles of the licensed therapies in the management of patients with RVO.
Conclusions
In conclusion, data from high-quality RCTs for ranibizumab and dexamethasone IVT have demonstrated that both new agents have promising outcomes for the treatment of BRVO and CRVO, and constitute significant improvements over the previously widely accepted standards of care (laser therapy for BRVO and no treatment for CRVO). Significant differences in study design and patient baseline characteristics prevent indirect comparisons being made between these treatments. Ranibizumab and dexamethasone IVT both produce rapid improvements in BCVA. These improvements appear to be maintained with initial monthly therapy followed by treatment as needed for ranibizumab, but decline 3 months after administration of the dexamethasone IVT implant. Dexamethasone IVT is associated with a significantly greater risk of increased IOP (which increased further with repeated treatment) and possibly an increased risk of cataract than is sham.
Head-to-head comparative studies are urgently needed to assess the relative efficacies of available licensed therapies for RVO. This is currently being assessed in three ongoing RCTs comparing ranibizumab with dexamethasone IVT in patients with RVO; the COMO (NCT01427751) and COMRADE B (NCT01396057) studies are being conducted in patients with BRVO and the COMRADE C study (NCT01396083) is being conducted in patients with CRVO. Direct comparison of the licensed therapies with laser monotherapy and the role of adjunctive laser therapy are currently lacking. This issue is being addressed by the RABAMES study (NCT00562406) comparing ranibizumab, laser monotherapy and ranibizumab plus adjunctive laser therapy in patients with BRVO; this study has been completed and data are expected shortly. A further study comparing similar treatment arms, the BRIGHTER study (NCT01599650, EUDRACT 2011–002859–34), has begun recruiting in Europe. Results from these studies should help to clarify the roles of the licensed therapies in the management of patients with RVO.
