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

Completed · Phase 2 · Has a placebo group

Conditions studied: Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT01397409

Run by

Allergan

People needed

271

Starts

2011-09-01

Expected to finish

2014-04-30

Last updated by the study team

2019-04-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Exudative age-related macular degeneration
• Best-corrected visual acuity between 20/32 and 20/320 in the study eye

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Sydney, New South Wales, Australia
• Study site — Vienna, Austria
• Study site — Créteil, France
• Study site — Bonn, Germany
• Study site — Tel Aviv, Israel
• Study site — Florence, Italy
• Study site — Binningen, Switzerland

Full record on ClinicalTrials.gov

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