2010-02: Long-term follow-up of Avastin-Injections in Age Related Macular Degeneration: Prospective Study for Optimal Frequency.
Age-related macular degeneration (ARMD) results in a deterioration of the central retinal function, and is the leading cause of blindness in people over 50 years of age in Europe and the USA. The wet form of ARMD, with choroidal neovascularization, is more aggressive and may progress more rapidly to blindness. Lucentis has been registered for treatment of wet ARMD, but Avastin appears to be a cost-effective alternative for Lucentis. An optimal injection schedule has not been determined so far. The objective of this randomized, prospective, open-label trial is to determine the optimal patient observation and Avastin injection schedule. Patients will be randomized towards a four-, six- or eight weekly injections and observation interval. After the initial follow-up of 1 year, all patients will be referred to the standard clinical care of the medical retina specialist. Follow-up of the Avastin-study patient will be extended until the moment that re-injection of Avastin is necessary to investigate the long-term effect of the treatment schedules. Criteria for re-injection are those standardly used by medical retina specialist: 1. symptoms of the patients; 2. visual acuity loss of > 1 Snellen line; 3. increase of > 50 µm fluid in OCT; 4. other fluid accumulation in OCT; 5. active ARMD in fundus. End of follow-up will be recorded as the time of re-injection.