NCT01397409

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	AGN-150998	AGN-150998 Intravitreal injection.
DRUG	ranibizumab	Ranibizumab 0.5 mg given by intravitreal injection.
OTHER	Sham Injection	Stage 3: Sham injection at Weeks 12 and 16.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-03-31
• Completion: 2014-04-30
• First posted: 2011-07-19
• Last updated: 2019-04-16
• Results posted: 2015-06-18

Locations

8 sites across 8 countries: United States, Australia, Austria, France, Germany, Israel, Italy, Switzerland