Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

• Status: Completed
• Trial end date: 2014-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Exudative age-related macular degeneration

• Best-corrected visual acuity between 20/32 and 20/320 in the study eye

Exclusion Criteria:

• Near-sightedness of 8 diopters or more

• Uncontrolled glaucoma in the study eye

• Cataract surgery or Lasik within the last 3 months

• Any active ocular infection or inflammation