Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
Status:
Completed
Trial end date:
2014-04-30
Target enrollment:
Participant gender:
Summary
This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of
the safety of AGN-150998 administered as a single intravitreal injection to patients with
advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are
randomized, double-masked, comparisons of the safety and treatment effects on retinal edema
and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive
patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a
fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest
tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on
retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of
AGN-150998.