Initial macular thickness and response to treatment in diabetic macular edema.

PURPOSE: To assess the effect of initial central macular thickness (CMT) on the response to treatment in diabetic macular edema. METHODS: The data of 150 eyes of 129 patients with clinically significant diabetic macular edema and no previous treatment who had been randomly assigned in the original trial to 1 of the 3 groups, 1) intravitreal bevacizumab (IVB) group (50 eyes); 2) combined intravitreal bevacizumab and triamcinolone (IVB/IVT) group (50 eyes); and 3) macular laser photocoagulation group (50 eyes), were reevaluated. This time the data of the cases were reanalyzed based on their initial CMT. Accordingly, the original treatment groups were categorized into 3 subgroups: 1) <250 µm, 2) 250 µm to 349 µm, and 3) ≥350 µm. Visual acuity and CMT changes in response to different treatments were compared. Main outcome measures were changes in visual acuity and CMT at Weeks 6, 12, 24, and 36. RESULTS: At 6 weeks in all subgroups, mean visual acuity improvement in the IVB group was significantly greater than the other groups (P = 0.002, P = 0.003, P < 0.001, for subgroups of <250, 250-349, and ≥350 µm, respectively). At 12, 24, and 36 weeks in the subgroup >350 µm and at 24 weeks in the subgroup 250 µm to 349 µm, the difference of mean visual acuity changes among the groups reached to a significant level (P = 0.010, P = 0.028, P < 0.001, and P < 0.001, respectively) in favor of the IVB group. The difference in mean CMT changes at 6 weeks and 12 weeks was significant among the groups in the subgroup ≥350 µm (P < 0.001 and P < 0.001) in favor of the IVB group and in the subgroup 250 µm to 349 µm at 24 weeks in favor of combined IVB/IVT group (P < 0.001). CONCLUSION: In the primary treatment of diabetic macular edema, initial CMT may be an important factor in decision making. Regardless of initial CMT, IVB caused a better visual outcome only at 6 weeks. With longer follow-up, however, IVB was superior to IVB/IVT and macular laser photocoagulation only in the eyes with initial CMT of ≥350 µm. Concerning CMT reduction, this superiority of IVB in the eyes with initial CMT of ≥350 µm was not observed beyond 12 weeks.

Diagnostic vitrectomy (25-gauge) in a case with intraocular lymphoma masquerading as bilateral granulomatous panuveitis.

PURPOSE: To report a case of intraocular lymphoma, masquerading as bilateral granulomatous panuveitis, and diagnosed after harvesting vitreous specimen with a 25-gauge vitrectomy instrument. METHODS: A 67-year-old woman presented with bilateral granulomatous uveitis. Visual acuity in both eyes was severely impaired because of severe concurrent cataract and vitreous organization. Sutureless phacoemulsification and posterior chamber intraocular lens implantation combined with 25-gauge diagnostic vitrectomy was performed. RESULTS: Cytopathology and immunocytochemistry of the vitreous disclosed a non-Hodgkin B-cell lymphoma despite unremarkable brain MRI, lumbar puncture, bone marrow aspiration, and whole body scan. Visual acuity improved to 20/120 in both eyes. CONCLUSIONS: Sutureless combined 25-gauge diagnostic vitrectomy, phacoemulsification, and posterior chamber intraocular lens implantation during one-stage surgery was effective in obtaining appropriate vitreous material for cytology in a case of intraocular lymphoma.

Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema.

PURPOSE: To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment of diabetic macular edema (DME). DESIGN: Randomized 3-arm clinical trial. PARTICIPANTS: A total of 150 eyes of 129 patients with clinically significant DME and no previous treatment. METHODS: The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB (50 eyes); the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT (50 eyes); and the MPC group, patients who underwent focal or modified grid laser (50 eyes). Retreatment was performed at 12-week intervals whenever indicated. MAIN OUTCOME MEASURES: Change in best-corrected visual acuity (VA) at week 24. RESULTS: VA changes among the groups were statistically significant at 6 (P<0.001) and 24 (P = 0.012) weeks. The significant treatment effect was demonstrated in the IVB group at all follow-up visits and in the IVB/IVT group at 6 and 12 weeks. VA changes +/- standard deviation at 36 weeks were -0.28+/-0.25, -0.04+/-0.33, and +0.01+/-0.27 logarithm of minimum angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively (P = 0.053). Significant central macular thickness (CMT) reduction was observed in all groups only up to 6 weeks; however, CMT changes were not significant among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks (14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group). In the IVB group, in which a greater VA improvement was observed, only 1 injection was required in 72% of the cases. VA improvement >2 Snellen lines at 36 weeks was detected in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT, and MPC groups, respectively. CONCLUSIONS: Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. A change in CMT beyond the 6-week time point that corresponded to the vision change was not detected. No adjunctive effect of IVT was demonstrated. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial.

PURPOSE: To evaluate the effect of three intravitreal injections of bevacizumab (IVB) alone or combined with triamcinolone (IVT) in the first injection for treatment of refractory diabetic macular edema (DME). METHODS: In this prospective, placebo-controlled, randomized clinical trial, 115 eyes of 101 patients with refractory DME were included. Subjects were randomly assigned to one of the three study arms: 1) three injections of IVB (1.25 mg/0.05 ml) at 6-week intervals, 2) combined IVB and IVT (1.25 mg/0.05 ml and 2 mg/0.05 ml respectively) followed by two injections of IVB at 6-week intervals, and 3) sham injection (control group). The primary outcome measure was change in central macular thickness (CMT). Secondary outcome measures were change in best-corrected logMAR visual acuity (BCVA ) and incidence of potential adverse events. RESULTS: Central macular thickness was reduced significantly in both the IVB and IVB/IVT groups. At week 24, CMT change compared to the baseline was -95.7 microm (95% CI, -172.2 to -19.26) in the IVB group, -92.1 microm (95% CI, -154.4 to -29.7) in the IVB/IVT group, and 34.9 microm (95% CI, 7.9 to 61.9) in the control group. There was a significant difference between the IVB and control groups (P = 0.012) and between the IVB/IVT and control groups (P = 0.022). Improvement of BCVA was initiated at weeks 6 and 12 in the IVB/IVT and IVB groups respectively. In terms of BCVA change compared to the baseline at 24 weeks, the differences between the IVB and control groups (P = 0.01) and also between the IVB/IVT and control groups (P = 0.006) were significant. No significant differences were detected in the changes of CMT and BCVA between the IVB and IVB/IVT groups (P = 0.99). Anterior chamber reaction was noticed in eight (19.5%) and seven (18.9%) eyes respectively in the IVB and IVB/IVT groups the day after injection, and it resolved with no sequel. Elevation of IOP occurred in three eyes (8.1%) in the IVB/IVT group. CONCLUSION: Three consecutive intravitreal injections of bevacizumab had a beneficial effect on refractory DME in terms of CMT reduction and BCVA improvement. Addition of triamcinolone in the first injection seemed to induce earlier visual improvement; however, it did not show any significant additive effect later during follow-up.

Intravitreal bevacizumab (avastin) injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic macular edema.

PURPOSE: To report the efficacy of a single intravitreal bevacizumab injection alone or in combination with intravitreal triamcinolone acetonide versus macular laser photocoagulation (MPC) as primary treatment of diabetic macular edema (DME). METHODS: In this randomized, three-arm clinical trial, 103 eyes of 97 patients with clinically significant DME and no previous treatment were enrolled. The eyes were randomly assigned to one of three study arms: the intravitreal bevacizumab (IVB) group, patients who received 1.25 mg of intravitreal bevacizumab (37 eyes); the IVB/IVT group, patients who received 1.25 mg of intravitreal bevacizumab and 2 mg of intravitreal triamcinolone (33 eyes); and the MPC group, patients who underwent focal or modified grid laser (33 eyes). Primary outcome measure was change in visual acuity. RESULTS: Visual acuity changes +/- SD at 12 weeks were -0.22 +/- 0.23, -0.13 +/- 0.31, and + 0.08 +/- 0.31 logarithm of the minimal angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively. The marginal regression model based on generalized estimating equation analysis demonstrated that the visual acuity changes in the groups were statistically significant at both 6 weeks (P < 0.0001) and 12 weeks (P = 0.024). The significant treatment effect was demonstrated at both 6 weeks and 12 weeks in the IVB group and only at 6 weeks in the IVB/IVT group. Significant central macular thickness (CMT) reduction was observed in eyes in the IVB and IVB/IVT groups only up to 6 weeks; however, CMT changes were not significant in the groups. CONCLUSION: Up to 12 weeks, intravitreal bevacizumab treatment of patients with DME yielded better visual outcome than laser photocoagulation, although it was not associated with a significant decrease in CMT. No further beneficial effect of intravitreal triamcinolone could be demonstrated. Further clinical trials with longer follow-up are required to evaluate the long-term visual outcomes and complication profiles after primary treatment with such medications.