Intravitreal ranibizumab for choroidal neovascularization secondary to angiod streaks. Comparison of the 12 and 24-month results of treatment in treatment-naïve eyes.

OBJECTIVE: Our aim study was to compare 12 and 24-month results of intravitreal ranibizumab therapy in the management of choroidal neovascularization (CNV) secondary to angioid streaks (ST). This could be of clinical importance helping us planning optimal dosing strategies. PATIENTS AND METHODS: Over a 7-year period, a consecutive series of treatment-naïve eyes with macular CNV due to AS were treated with intravitreal ranibizumab (0.5 mg). The main outcome measure was changed in best-corrected visual acuity (BCVA) at 12 and 24 months as compared to baseline. RESULTS: Twenty eyes completed 24-month therapy and regular follow-up visits. BCVA improved at 12 (0.42±0.26 logMAR) and 24 months (0.44±0.22 logMAR) as compared to baseline (0.75±0.26 logMAR) (p<0.001), but did not change between the 12 and 24-month follow-up (p=0.48). BCVA improved in 15 (75%) and 16 (80%) of the eyes, but in 5 (25%) and 4 eyes (20%) remained unchanged (p=0.71) at 12 and 24 months, respectively. CONCLUSIONS: These results suggest that during the first year of intravitreal ranibizumab therapy for patients with macular CNV due to AS, BCVA improved in most of the eyes, and was maintained during the second year.

Good manufacturing practice-compliant validation and preparation of BM cells for the therapy of acute myocardial infarction.

BACKGROUND: Intracoronary application of BM-derived cells for the treatment of acute myocardial infarction (AMI) is currently being studied intensively. Simultaneously, strict legal requirements surround the production of cells for clinical studies. Thus good manufacturing practice (GMP)-compliant collection and preparation of BM for patients with AMI was established by the Cytonet group. METHODS: As well as fulfillment of standard GMP requirements, including a manufacturing license, validation of the preparation process and the final product was performed. Whole blood (n=6) and BM (n=3) validation samples were processed under GMP conditions by gelafundin or hydroxyethylstarch sedimentation in order to reduce erythrocytes/platelets and volume and to achieve specifications defined in advance. Special attention was paid to the free potassium (<6 mmol/L), some rheologically relevant cellular characteristics (hematocrit <0.45, platelets <450 x 10(6)/mL) and the sterility of the final product. RESULTS: The data were reviewed and GMP compliance was confirmed by the German authorities (Paul-Ehrlich Institute). Forty-five BM cell preparations for clinical use were carried out following the validated methodology and standards. Additionally three selections of CD34+ BM cells for infusion were performed. All specification limits were met. Discussion In conclusion, preparation of BM cells for intracoronary application is feasible under GMP conditions. As the results of sterility testing may not be available at the time of intracoronary application, the highest possible standards to avoid bacterial and other contaminations have to be applied. The increased expense of the GMP-compliant process can be justified by higher safety for patients and better control of the final product.