Macugen maintenance

Article

Macugen maintenance

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.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Recent Videos
Jeremiah Tao, MD, FACS, discusses his Egyptian Ophthalmological Society keynote, which focused on risk management and avoiding surgical complications in oculofacial surgery
Omer Trivizki, MD, MBA, a retina specialist from Tel Aviv Medical Center, speaks about VOY-101, a Novel, Complement-Modulating Gene Therapy for Geographic Atrophy at the American Society of Retina Specialists (ASRS) Annual Meeting
João Pedro Marques, MD, MSc, PhD discusses a retrospective study of 800 patients with inherited retinal diseases during the American Society of Retina Specialists (ASRS) annual meeting
© 2025 MJH Life Sciences

All rights reserved.