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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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Phoenix, Arizona, United States
Sydney, New South Wales, Australia
Vienna, Austria
Créteil, France
Bonn, Germany
Tel Aviv, Israel
Florence, Italy
Binningen, Switzerland
Start Date
September 1, 2011
Primary Completion Date
March 31, 2014
Completion Date
April 30, 2014
Last Updated
April 16, 2019
271
ACTUAL participants
AGN-150998
DRUG
ranibizumab
DRUG
Sham Injection
OTHER
Lead Sponsor
Allergan
NCT05913063
NCT06990269
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06970665