Study Complete
Sponsor ID
20170542

A Study to understand Effectiveness and Safety of ABP 938 compared to Aflibercept (Eylea®) in patients suffering with Neovascular Age-related Macular Degeneration [neovascular (wet) AMD]

Sponsor ID
20170542
Clinicaltrials.gov ID
NCT04270747
EUCTIS ID
N/A
EudraCT ID
2019-002503-17

Study Details

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
576
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from Baseline in Best Corrected Visual Acuity (BCVA)

Timeframe: At week 8

Secondary Outcome Measures

Change from Baseline in ETDRS letter score at week 52 maintaining vision lost fewer than 15 letters

Timeframe: At week 52

Change from Baseline in BCVA

Timeframe: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52

Change from Baseline in ETDRS letter score at week 8 and week 52

Timeframe: At week 8 and week 52

Change from Baseline in Choroidal Neovascularization (CNV) area

Timeframe: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52

Change from Baseline in Central Subfield Thickness (CST)

Timeframe: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52

Number of subjects with incidence of Antidrug Antibodies (ADA)

Timeframe: At day 1, week 8, week 16, week 24, week 40 and week 52

Number of subjects with treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events

Timeframe: Upto 56 weeks

Locations

Location
Status
Contact Us
Location
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Status
Completed
Location
Southeast Retina Center
Augusta, Georgia, United States, 30909
Status
Recruiting
Location
Sterling Research Group
Cincinnati, Ohio, United States, 45219
Status
Recruiting
Location
Texas Retina Associates
Dallas, Texas, United States, 75231
Status
Completed
Location
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary, 4032
Status
Recruiting
Location
Retina Associates IL
Elmhurst, Illinois, United States, 60126
Status
Completed
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