Table 2.
Trial | Dosage range | Duration | Patients | Results | References |
---|---|---|---|---|---|
Phase I | 0.25’30 mg/eye | 3 months | 15 | 80% had stabilized or improved vision with 26.7% showing improvement, no toxicity | Guyer et al 2002; Eyetech Study Group 2002 |
Phase II | multiple intravitreal injections with or without PDT | 3 months | 21 | vision stabilized or improved in 87.5%, 25% showed 3 lines or greater improvement, when combined with PDT, improvement of 3 lines or greater reached 60% | Guyer et al 2003; Eyetech Study Group 2002 |
Phase III | 0.3, 1.0, or 3.0 mg/eye | 54 week | 1186 | efficacy demonstrated for all 3 doses without a dose-dependency relationship, 15%–24% improvement (depending on the evaluation) in number of patients that lost fewer than 15 letters of visual acuity, 2.2–9.7x greater risk of severe visual loss (≥30 letters), 10% improvement in patients that maintained or gained visual acuity, adverse effects accounting for severe loss of visual acuity in 0.1% | Gragoudas et al 2004; VISION Clinical Trial Group 2005 |
Abbreviations: PDT photodynamic therapy.