| 1 |
Clinical Conference A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. free! 2007
Anonymous00409, Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR. · Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647, USA. · Ophthalmology. · Pubmed #17698196 links to free full text
Abstract: OBJECTIVE: To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME). DESIGN: Randomized phase II clinical trial. PARTICIPANTS: One hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320. INTERVENTIONS: Random assignment to 1 of 5 groups: (A) focal photocoagulation at baseline (n = 19), (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks (n = 22), (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and 6 weeks (n = 24), (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at 6 weeks (n = 22), or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (n = 22). MAIN OUTCOME MEASURES: Central subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks. RESULTS: At baseline, median CST was 411 mum and median Snellen VA equivalent was 20/50. Compared with group A, groups B and C had a greater reduction in CST at 3 weeks and about 1 line better median VA over 12 weeks. There were no meaningful differences between groups B and C in CST reduction or VA improvement. A CST reduction > 11% (reliability limit) was present at 3 weeks in 36 of 84 (43%) bevacizumab-treated eyes and 5 of 18 (28%) eyes treated with laser alone, and at 6 weeks in 31 of 84 (37%) and 9 of 18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in 1 eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (n = 2), congestive heart failure (n = 1), elevated blood pressure (n = 3), and worsened renal function (n = 3). CONCLUSION: These results demonstrate that intravitreal bevacizumab can reduce DME in some eyes, but the study was not designed to determine whether treatment is beneficial. A phase III trial would be needed for that purpose.
|
| 2 |
Clinical Conference Electrophysiologic findings after intravitreal bevacizumab (Avastin) treatment. 2006
Maturi RK, Bleau LA, Wilson DL. · Vitreo-retinal Service, Midwest Eye Institute, Indianapolis, Indiana 46280, USA. · Retina. · Pubmed #16508425 No free full text.
Abstract: PURPOSE: To evaluate the short-term electrophysiologic effects of intravitreal bevacizumab in the treatment of exudative age-related macular degeneration (AMD). METHODS: Nine subjects with AMD who received treatment with intravitreal bevacizumab for exudative AMD underwent pretreatment testing with multifocal electroretinography (mf-ERG) or Ganzfeld electroretinography (G-ERG). All five G-ERG subjects underwent repeated testing at 1 week after intravitreal bevacizumab. All four mf-ERG subjects and four of the five G-ERG subjects underwent repeated testing with the same pretreatment protocol at 1 month after treatment. One G-ERG subject also received a second intravitreal injection of bevacizumab at 6 weeks after initial treatment and underwent repeated testing at 1 month after the second dose (3 months after initial treatment). RESULTS: All four subjects undergoing mf-ERG had improvement of the macular response at 1 month of after treatment. The average improvement in response density of the central 15 degrees of macular response was 35% (range, 11-65%). Subjects undergoing G-ERG testing had no significant changes in electrophysiologic response, although some variation in amplitude and implicit time was noted at different testing times. Optical coherence tomography central subfield thickness decreased from 298 microm at baseline to 274 microm at 1 month after treatment. Visual acuity improved in a majority of subjects. CONCLUSION: In this study, the intravitreal use of bevacizumab resulted in improvement of mf-ERG macular function responses and relatively stable G-ERG responses. The macular electrophysiologic response suggests that macular function improves with treatment. G-ERG suggests that there is no significant measurable photoreceptor toxicity with the use of intravitreal bevacizumab over the short term.
|