Clinical trial NCT01397409: Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-related Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 271
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Highest Tolerated Dose (HTD) of AGN-150998
timeFrame: 24 Weeks
measure: Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline, Week 4
measure: Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
timeFrame: Baseline, Week 16
measure: Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Stage 2: Time Between Second Treatment and Recurrence of Active Disease
timeFrame: 32 Weeks
measure: Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline, Week 4
measure: Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Week 4
measure: Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline, Week 4
measure: Stage 3: Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Sydney
country: Australia
state: New South Wales
city: Vienna
country: Austria
city: Créteil
country: France
city: Bonn
country: Germany
city: Tel Aviv
country: Israel
city: Firenze
country: Italy
city: Binningen
country: Switzerland
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, Lopez FJ, Schneider S. Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2018 Dec;34(10):700-709. doi: 10.1089/jop.2018.0062. Epub 2018 Nov 9.