Intravitreal administration of 1.25 mg of bevacizumab during cataract surgery was shown to be safe and effective in preventing the progression of diabetic retinopathy and diabetic maculopathy in patients with cataract and DR in a recent study in Suadi Arabia.
In the prospective randomized study, 68 eyes of 68 patients with DR and cataracts were randomized to receive either a standardized procedure of phacoemulsification with intraocular lens implantation alone (control group) or to receive 1.25 mg intravitreal bevacizumab at the end of surgery (intervention group). Diabetic retinopathy and maculopathy were assessed at each postoperative visit during a six-month follow-up.
Results showed that progression of DR occurred in 15 (45.45 percent) of 33 eyes in the control group and four (11.42 percent) of 35 eyes in the intervention group (p=.002). Progression of diabetic maculopathy occurred in 17 eyes (51.51 percent) in the control group and two eyes (5.71 percent) in the intervention group (p=.0001). Testing showed no statistically significant difference in postoperative visual acuity between the two groups (p=.772). Two eyes in the control group and none in the intervention group progressed to neovascular glaucoma. The two groups showed no statistically significant difference in the mean postoperative central macular thickness or the mean macular thickness (p=.874 and .942, respectively).
(J Cataract Refract Surg 2009;35:18-25)
Cheema RA, Al-Mubarak MM, Amin YM, Cheema MA.
Abstracts Don't Always Jibe with Outcomes Measures
When reading industry-funded studies, it may be advisable to check the abstract's conclusions against the outcome measures, according to recent literature review.
Due to the increase in research funded by pharmaceutical companies as well as drug companies that conduct their own research, the study was conducted to investigate the relationship between industry- vs. non-industry-funded publications to compare the efficacy of topical prostaglandin analogs by evaluating the correspondence between the statistical significance of the publication's main outcome measure and its abstract conclusions.
The retrospective, observational cohort study by researchers in
The main outcome measure was correspondence between abstract conclusion and reported statistical significance of the publications' main outcome measure.
Results showed that the published abstract conclusion was not consistent with the results of the main outcome measure in 18 (62 percent) of 29 of the industry-funded studies compared with none of 10 of the non-industry-funded studies (p=.0006). Twenty-six (90 percent) of the industry-funded studies had abstract conclusions that came across as pro-industry. Twenty-four percent of the industry-funded publications had a statistically significant main outcome measure; however, 90 percent of the industry-funded studies had pro-industry abstract conclusions, showing that readers should scrutinize the journals to make sure information is supportive of the author's conclusion.
(Am J Ophthalmol. 2009;147:33-38)
Alasbali T, Smith M, Geffen N, Trope GE, et al.
Ranibizumab Improves PDT Treatment
Patients treated with ranibizumab proved more likely to show clinically meaningful improvements in visual function when compared with patients treated with verteporfin photodynamic therapy, a study shows.
The randomized clinical study compared two neovascular AMD treatments and patient-reported improvements in vision-related function.
In the multicenter, double-masked, Phase III trial (ANCHOR), participants were randomized in a 1:1:1 ratio to receive 0.3 or 0.5 mg of intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered at baseline and one, two, three, six, nine, 12, 18 and 24 months. The mean change from baseline in NEI VFQ-25 scores would be measured at 12 months.
At the 12-month mark, patients treated with ranibizumab (0.3 mg [n=137] or 0.5 mg [n=139]) had mean improvements in NEI VFQ-25 composite scores of 5.9 (95 percent confidence interval, 3.6 to 8.3) and 8.1 (95 percent CI, 5.3 to 10.8) points, respectively; patients treated with PDT (n=142) had a mean improvement of 2.2 points (95 percent CI, -0.3 to 4.7; vs. 0.5 mg of ranibizumab, p<.001; vs. 0.3 mg of ranibizumab, p=.003).
After 24 months of each dose, patients treated with ranibizumab were more likely to improve in most subscales (including the prespecified subscales, such as near activities, distance activities and vision-specific dependency) than with PDT.
(Arch Ophthalmol. 2009;127:13-21)
Bressler N, Chang T, Fine J, Dolan C, et al.
Treating AMD with PDT/bevacizumab
A customized approach to PDT combined with bevacizumab has proven as effective as monotherapy in improving vision in AMD, but with fewer intravitreal injections.
A study tested 63 patients with exudative AMD to research the effects of the combination in choroidal neovascularization associated with AMD. Each patient was treated with an initial dose of PDT and intravitreal bevacizumab 24 to 48 hours afterwards. Retreatments were carried out as required with monthly bevacizumab and PDT every three months if there were relapses. Follow-up lasted one year in all cases.
The mean best-corrected visual acuity increased by 4.85 letters after the first month, eventually reaching 5.65 letters at the 12-month follow-up (p<0.05).
Compared with initial vision, 79.3 percent of the eyes had the same or better vision and 95.2 percent lost fewer than 15 letters. The total number of PDT treatments was 92 (a mean of 1.46 treatments per patient). The mean number of bevacizumab injections was two per patient. In 29 cases (46 percent), only one initial treatment with PDT/ bevacizumab was necessary. In 15 cases (23.8 percent), more than two combined treatments per patient were necessary.
(Retina 2009;29:13-19)
Navea A, Mataix J, Desco MC, et al.
