Ten studies were included in the review (covering 295 patients and over 1,280 injections); one study included 227 patients. The mean follow-up period was 74 months (range two to 91 months).
Ocular side effects occurred in 38 patients: 17 were significant and 21 were minor. The proportion of patients experiencing potentially significant ocular side effects following standard melphalan regimens was 0.031 (95% CI 0.013 to 0.06) representing eight of 261 patients. The side effects in the eight patients included iris atrophy (three patients), chorioretinal atrophy (two patients), vitreous haemorrhage (two patients) and retinal detachment (one patient). All eight patients were from one study (the largest study).
Of the other nine patients with significant complications: five patients experienced sight-threatening complications following dramatic dose escalations (four with melphalan, one with thiotepa); three patients experienced complications commonly associated with concurrent therapies given to these patients; and one patient had a retinal detachment.
Of the 61 patients who received intravitreal injection therapy by safety-enhancing injection techniques, all six significant side effects were either attributed to the therapeutic dose or confounded by concurrent treatments.