OSI Pharmaceuticals and Pfizer have announced the initiation of a Phase IV trial to explore the safety and efficacy of Macugen (pegaptanib sodium injection) as a maintenance therapy for patients who have received prior wet age related macular degeneration (AMD) treatment and experienced improvement in their condition.
LEVEL (evaLuation of Efficacy and safety in maintaining Visual acuity with sEquential treatment of neovascuLar AMD), is an open label, multicentre trial, open to subjects who have had at least one, but no more than three, treatments for wet AMD within 30 to 120 days prior to the study. The 54-week trial comprises of up to 1,000 patients at 100 sites across the USA. Macugen will be administered once every six weeks for 48 weeks, booster treatment may be employed if the investigator believes macular disease has progressed.
The primary endpoint is the percentage of patients who remain at baseline vision or gain (more than or equal to 0 lines) vision from baseline to 54 weeks. Secondary endpoints include the percentage of patients maintaining or gaining one, two and three lines of visual acuity at week 54 compared with pre-enrolment baseline vision; mean change of visual acuity from baseline to week 54; percentage of subjects losing less than three lines of vision at week 54; and anatomical outcomes on fluorescein angiography and optical coherence tomography.
Macugen is already an approved treatment for wet AMD in North America, Europe, Brazil, Argentina, Peru, Pakistan and The Philippines. This study hopes to demonstrate that the drug can continue to be effective over an extended period of time.