An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema.

AIM: The aim of the study was to assess the safety and bioactivity of a single intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye in subjects with diabetic macular oedema (DMO). METHODS: Five subjects with DMO, foveal thickness > or =250 microm measured by optical coherence tomography (OCT), and best-corrected visual acuity (BCVA) between 20/40 and 20/320, were enrolled. Each participant received a single intravitreal injection of 4.0 mg of VEGF Trap-Eye followed by a 6-week observation period. Outcome measures included safety and biological activity, including changes in BCVA and excess retinal thickness assessed by OCT. RESULTS: Injections of VEGF Trap-Eye were well tolerated with no ocular toxicity. One patient had an unrelated serious adverse event: hospitalisation for cellulitis of the left foot 27 days after injection of VEGF Trap-Eye. Median baseline BCVA was 36 ETDRS letters read at 4 m (not ETDRS visual acuity score; Snellen equivalent: 20/50) and median baseline excess central 1 mm foveal thickness (FTH) was 108 microm. At 4 weeks after injection, the median excess FTH was 59 microm and the median improvement in BCVA was nine letters. At 6 weeks after injection, four of the five patients showed improvement in excess FTH (median 74 microm; 31% reduction from baseline, p = 0.0625) and four of the five showed improvement in BCVA (median improvement of three letters). CONCLUSIONS: A single intravitreal injection of 4.0 mg of VEGF Trap-Eye was well tolerated and preliminary evidence of bioactivity was detected. These findings support additional studies investigating multiple injections of VEGF Trap-Eye in patients with DMO.

Transurethral evaporation of prostate (TUEP) with Nd:YAG laser using a contact free beam technique: results in 61 patients with benign prostatic hyperplasia.

OBJECTIVE: This prospective study was undertaken to evaluate the safety and efficacy of neodymium:yttrium-aluminium-garnet (Nd:YAG) laser for treatment of symptomatic benign prostatic hyperplasia (BPH). METHODS: A total of 61 patients at a mean age of 71.6 years with symptomatic bladder outlet obstruction due to BPH underwent transurethral evaporation of prostate (TUEP) using Nd:YAG laser. Twelve of the patients were experiencing acute retention. Pre- and postoperative evaluation consisted of American Urological Association (AUA) symptom questionnaire and a sexual function questionnaire, uroflowmetry, postvoid residual urine, electrolytes, blood urea nitrogen, creatinine, hematocrit, and prostate volume estimation by transrectal ultrasound. TUEP was achieved by employing a side-firing Nd:YAG laser fiber with a durable quartz reflector and high-power density (Ultraline, Heraeus LaserSonics, Milpitas, CA) that was used in a contact mode. RESULTS: All patients have been evaluated for three months, 26 for six months, and 7 for twelve months. Mean prostatic size was 41.1 g. The mean improvement in symptom scores at one, three, six, and twelve months was 69.8 percent, 70.9 percent, 76.0 percent, and 70.9 percent, respectively (P = < 0.0001). The mean increase in maximum uroflow at one, three, six, and twelve months was 63.4 percent, 66.7 percent, 41.94 percent, and 164.52 percent, respectively (P = < 0.0001). There was no instance of significant fluid absorption or bleeding. The duration of postoperative catheterization was two days in 43 patients, three to seven days in 16 patients, and two to three weeks in 2 patients. There were no deaths. All patients evaluated by TRUS at six months had open channeling defects. Videocystoscopy performed in 16 patients at two to three months postoperatively revealed tissue slough. At repeat cystoscopy in these patients at six months, the prostatic fossa was completely healed with no evidence of tissue slough. CONCLUSIONS: It is concluded that the technique of TUEP using Nd:YAG laser is safe and, in preliminary results, appears apparently effective in the management of BPH.

Negative repeat transurethral resection of prostate fails to identify patients with stage A1 prostatic carcinoma at lower risk of progression: a long-term study.

Stage A1 (low-grade and low-volume) adenocarcinoma is associated with a low likelihood of progression. Repeat transurethral resection has been used to identify patients at increased risk (residual cancer noted) as well as those at low risk of progression (no residual cancer noted). We recently evaluated the ability of this technique to define a low-risk patient population. We reviewed the records of 24 patients who underwent repeat transurethral resection after they were identified as having Stage A1 prostatic cancer on initial resection (Gleason score < 5, tumor volume comprising < 5% of the resection specimen). Despite no evidence of residual carcinoma on repeat resection, 3 patients (13%) progressed at a mean follow-up of seven years (2 locally, 1 locally and distantly). We conclude that repeat resection does not effectively evaluate the risk of progression and that other techniques including transrectal ultrasonography and serial prostate-specific antigen measurements should be similarly evaluated.