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Prior to the initiation of each trial, the occlusion goggles were either opened by the experimenter for a vision trial or remained closed for an occluded trial.
The details of the design of the VISION trial have been reported.
The data from the VISION trial demonstrate a favourable ocular and systemic safety profile for 3 years of continuous selective VEGF inhibition with pegaptanib sodium for the treatment of NV-AMD.
23 25 We now present further data for patients who have continued for 3 years in the VEGF Inhibition Study in Ocular Neovascularisation (VISION) trial, showing that no new safety signals have emerged over this additional period.
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These (which formed part of the full vision trials) involved increasing the height of the raised surface, out of view of participants, by 15 mm (to give a total height of 161 mm) and were undertaken every third trial.
As in the VISION trials, 8 9 pegaptanib was well tolerated, with few ocular or systemic events.
These rates are similar to those observed in the VEGF Inhibition Study in Ocular Neovascularization (VISION) trials' pegaptanib 0.3 mg group at 1 year (Pfizer Inc, data on file).
The primary efficacy outcome of the VEGF Inhibition Study in Ocular Neovascularization (VISION) trials was the proportion of patients who lost <15 letters of VA between baseline and week 54.
The underlying objective of this study was to explore outcomes obtained by combining the safety record of pegaptanib, now validated over 4 years in the continuation of the VISION trials, 9 after visual gains were obtained during an induction phase.
In the NF field, 4 trials were removed out of the 320 trials total (vision: 1 trial; no vision 3 trials).
Out of the trials remaining, 6 trials out of the 320 trials were removed (vision: 3 trials; no vision 3 trials).
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