Intravitreal bevacizumab (Avastin) for persistent new vessels in diabetic retinopathy (IBEPE study): 1-year results.

PURPOSE: To evaluate the effect of intravitreal bevacizumab on area of fluorescein leakage from active new vessels (NVs) and on best-corrected visual acuity in patients with actively leaking NV associated with diabetic retinopathy unresponsive to panretinal photocoagulation. METHODS: A prospective open-label study of diabetic patients with actively leaking NV refractory to panretinal photocoagulation and best-corrected visual acuity worse than 20/40. Ophthalmic evaluation, including fluorescein angiography, was performed at baseline and at Weeks 1, 6, 12, 24, and 48 after intravitreal bevacizumab (1.5 mg/0.06 mL) injection. After Week 12, patients could receive additional intravitreal bevacizumab injections pro re nata, per the discretion of the treating ophthalmologist. Main outcome measures include change from baseline (at each study visit) in total area of fluorescein leakage from active NV and change from baseline in best-corrected visual acuity. RESULTS: Fifteen consecutive patients were included, and 12 completed the study. Mean ± SEM fluorescein leakage was 27.7 ± 6.2 mm at baseline and was significantly lower at all visits post injection; at Week 6, no leakage was observed (P = 0.0001). The mean ± SEM logarithm of minimum angle of resolution best-corrected visual acuity improved from 0.90 ± 0.11 at baseline to 0.70 ± 0.12 at Week 48 (P = 0.0449). Throughout the 48-week study period, patients received a mean of 2.16 injections. CONCLUSION: With 1-year follow-up, treatment with intravitreal bevacizumab was associated with reduced fluorescein leakage from persistent NV and improved visual acuity in patients with diabetic retinopathy unresponsive to panretinal photocoagulation.

Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab.

BACKGROUND AND OBJECTIVE: To compare the analgesic effectiveness and aesthetic appearance associated with topical, subconjunctival, and peribulbar anesthesia for intravitreal bevacizumab injection. PATIENTS AND METHODS: Sixty consecutive patients undergoing their first intravitreal bevacizumab injection were randomized to receive one of three forms of anesthesia: proxymetacaine eye drops, subconjunctival injection of 2% xylocaine, and peribulbar injection of 2% xylocaine. Pain associated with the intravitreal injection and with the entire procedure (including anesthesia administration) was recorded using a Visual Analog Scale 15 minutes after intravitreal injection. Anterior segment evaluation was performed 24 hours after injection to measure the number of clock hours of subconjunctival hemorrhage. RESULTS: Median injection-related pain score was significantly lower in the peribulbar group compared with the topical and subconjunctival groups (P < .05). Median entire procedure pain score was significantly higher in the peribulbar group compared with the topical and subconjunctival groups (P < .05). The median extent of subconjunctival hemorrhage was significantly lower in the topical group compared with the other groups (P < .05). CONCLUSION: Among the three anesthetic techniques, peribulbar anesthesia was associated with greater effectiveness in controlling injection-related pain but was least effective in controlling entire procedure pain. There was no significant difference in pain scores between the topical and subconjunctival groups, and topical anesthesia was associated with less subconjunctival hemorrhage.

Intravitreal bevacizumab (Avastin) for persistent new vessels in diabetic retinopathy (IBEPE study).

OBJECTIVE: To evaluate the short-term fluorescein angiographic and visual acuity effects of a single intravitreal injection of bevacizumab (Avastin) for the management of persistent new vessels (NV) associated with diabetic retinopathy. METHODS: A prospective, nonrandomized open-label study of diabetic patients with actively leaking NV refractory to laser treatment and best-corrected Early Treatment Diabetic Retinopathy Study visual acuity (BCVA) worse than 20/40. Standardized ophthalmic evaluation was performed at baseline and at weeks 1, 6, and 12 (+/-1) following intravitreal injection of 1.5 mg of bevacizumab. Main outcome measures include changes in total area of fluorescein leakage from active NV and BCVA. RESULTS: Fifteen consecutive patients (men, 9 [60%]; women, 6 [40%]) were included and all completed the 12-week follow-up period of the study. The mean +/- SD age of participants was 60.08 +/- 7.75 years (median, 59.5; range, 49-73 years). At baseline, mean +/- standard error of the mean (SEM) NV leakage area was 27.79 +/- 6.29 mm2. The mean +/- SEM area of active leaking NV decreased significantly to 5.43 +/- 2.18 mm2 and 5.50 +/- 1.24 mm2 (P < 0.05, Tukey multiple comparisons post-test) at 1 and 12 weeks postinjection, respectively; at week 6 no leakage was observed. The mean +/- SEM logMAR (Snellen equivalent) BCVA improved significantly from 0.90 (20/160) +/- 0.11 at baseline to 0.76 (20/125(+2)) +/- 0.12, 0.77 (20/125(+2)) +/- 0.11, and 0.77 (20/125(+2)) +/- 0.12 at weeks 1, 6, and 12, respectively (P < 0.05, Tukey multiple comparisons post-test). No major adverse events were observed. CONCLUSIONS: Intravitreal injection of bevacizumab achieved short-term reduction of fluorescein leakage from persistent active NV without loss of vision in patients with diabetic retinopathy. Further studies to investigate the role of anti-VEGF therapy with bevacizumab for the management of diabetic retinopathy refractory to laser treatment are warranted.