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 |
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
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