Sustained elevation in intraocular pressure associated with intravitreal bevacizumab injections.

This retrospective case series reports sustained elevation of intraocular pressure (IOP) after single or repeated intravitreal injections of bevacizumab (Avastin; Genentech, San Francisco, CA) for wet age-related macular degeneration (AMD). All six cases experienced significant and sustained elevation in IOP after single or repeated intravitreal injections of bevacizumab. Initiation or advancement of IOP-lowering therapy was required in all cases. The results support the need for further studies investigating the incidence of this potential side effect and the need for close long-term surveillance of IOP after injection of bevacizumab, particularly in patients with glaucoma or suspected glaucoma. Future in vitro and in vivo studies are needed to better understand the reasons for this observed phenomenon.

Surveillance for potential adverse events associated with the use of intravitreal bevacizumab for retinal and choroidal vascular disease.

PURPOSE: To systematically study potential adverse events associated with the use of intraocular bevacizumab at a single medical center. METHODS: Retrospective study of all consecutive patients receiving intraocular bevacizumab injections at the Stanford University Department of Ophthalmology between November 15, 2005 and July 14, 2006. Bevacizumab was given for exudative age-related macular degeneration, retinal vascular occlusion, diabetic macular edema, neovascular glaucoma, and five other indications. RESULTS: We analyzed medical records of 186 subjects (203 eyes) who received a total of 578 injections of 1.25 mg of bevacizumab. The average follow-up was approximately 6 months. Five eyes with exudative age-related macular degeneration developed retinal pigment epithelial (RPE) tears, all with preexisting RPE detachments. These five eyes represented 2.9% of all age-related macular degeneration eyes treated and 7% of the age-related macular degeneration eyes with preexisting RPE detachments at initiation of treatment. Other adverse events were rare and included retinal ischemia, subretinal hemorrhage, vitreous hemorrhage, ocular irritation or pain, worsened hypertension, and headache. No death or thromboembolic events were observed. CONCLUSION: Intraocular bevacizumab appears to be well tolerated for the treatment of a variety of retinal and choroidal vascular diseases. RPE tears may occur when treating choroidal neovascularization, particularly in patients with preexisting RPE detachment.

Shedding and reversion of oral polio vaccine type 3 in Mexican vaccinees: comparison of mutant analysis by PCR and enzyme cleavage to a real-time PCR assay.

A uracil-to-cytosine mutation at nucleotide position 472 of oral poliovirus vaccine type 3 (OPV3) contributes to the development of vaccine-associated paralytic poliomyelitis (VAPP). To analyze OPV3 shedding patterns, we previously used the multistep method of mutant analysis by PCR and enzyme cleavage (MAPREC). This involves conventional reverse transcription-PCR to detect OPV3, followed by a restriction digest to quantify position 472 reversion. Real-time PCR detects and quantifies nucleic acid as PCR occurs and avoids postreaction processing. The goal of this study was to compare a real-time PCR method to MAPREC. Seventy-three stool samples from Mexican OPV recipients underwent the reverse transcription-PCR step of MAPREC and real-time PCR. Real-time PCR identified 23% more OPV3-positive samples than conventional reverse transcription-PCR. When reversion was compared, the revertant proportion (RP), defined as the percentage of revertants in a sample, differed by < or =10% in 21/25 (84%) samples. The four samples differing by >10% were obtained within 5 days of OPV administration. The real-time PCR assay identified samples with an RP of > or =85% with 94% sensitivity and 86% specificity compared to MAPREC. The mean difference in RP between the two methods was 3.6% (95% confidence interval, -0.3 to 7.5%). Real-time PCR methods reliably detect OPV3, and reversion estimates correlate more consistently with MAPREC when OPV3 reversion rates are high. Detecting VAPP-related mutations by real-time PCR is rapid and efficient and can be useful in monitoring ongoing global polio eradication efforts.

Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus.

BACKGROUND: A new continuous glucose monitoring system (CGMS Datalogger, Medtronic MiniMed, Northridge, CA) potentiates extended sensor use by eliminating the cable connection to a monitor and by being waterproof. We evaluated the performance, safety, and patient tolerance of using the CGMS for 7 continuous days in children with type 1 diabetes mellitus who were encouraged to participate fully in their usual sports and activities in their home environment. METHODS: Twenty pediatric subjects (12.2 +/- 4.6 years old [mean +/- SD] and glycosylated hemoglobin of 8.06 +/- 1.22%) wore two CGMS devices simultaneously for 7 days. Sensor function was assessed by paired sensor-meter values obtained from the CGMS and their Paradigm Link (Medtronic Minimed) home glucose meter and a daily patient log of sensor and Datalogger sites. RESULTS: Subjects were wearing 90% of the sensors at the end of 7 days. The devices were well tolerated except for pruritus at the adhesive sites in 29% of subjects, and one sensor site (3%) became infected. Once a correction was made to the connection between the cable and Datalogger, 89% of the 18 sensors that initialized were functional at the end of 5 days [r = 0.91; percent mean absolute relative difference (%MARD) = 12.4%], and 78% were functioning at the end of 7 days (r = 0.91; %MARD s 15.4%). Patient comfort while wearing the device decreased after 5 days of sensor wear. CONCLUSIONS: This study demonstrates that the life of the glucose sensor can be extended well beyond the current labeling of 72 h. Once the cable connection was corrected, there was no statistically significant change in sensor performance over 7 days. Patients preferred to wear the device for a maximum of 5-6 days.