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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:11/30/2013
Start Date:September 2011
End Date:September 2014
Contact:Allergan Inc
Email:clinicaltrials@allergan.com

Use our guide to learn which trials are right for you!


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.


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
We found this trial at
1
site
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials