OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Key facts

Study ID

NCT04757636

Run by

Opthea Limited

People needed

998

Starts

2021-03-12

Expected to finish

2025-03-31

Last updated by the study team

2025-08-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
• Main Exclusion Criteria:
• Any previous treatment for neovascular AMD.
• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
• Additional inclusion/exclusion criteria apply.

Where it is running

• COAST Investigational Site — Arcadia, California, United States
• COAST Investigational Site — Huntington Beach, California, United States
• COAST Investigational Site — Redlands, California, United States
• COAST Investigational Site — Sacramento, California, United States
• COAST Investigational Site — Danbury, Connecticut, United States
• COAST Investigational Site — Altamonte Springs, Florida, United States
• COAST Investigational Site — Boynton Beach, Florida, United States
• COAST Investigational Site — Coral Springs, Florida, United States
• COAST Investigational Site — Melbourne, Florida, United States
• COAST Investigational Site — Orlando, Florida, United States
• COAST Investigational Site — Plantation, Florida, United States
• COAST Investigational Site — Sarasota, Florida, United States
• COAST Investigational Site — St. Petersburg, Florida, United States
• COAST Investigational Site — Stuart, Florida, United States
• COAST Investigational Site — Winter Haven, Florida, United States
• COAST Investigational Site — Marietta, Georgia, United States
• COAST Investigational Site — ‘Aiea, Hawaii, United States
• COAST Investigational Site — Chicago, Illinois, United States
• COAST Investigational Site — Springfield, Illinois, United States
• COAST Investigational Site — Urbana, Illinois, United States
• COAST Investigational Site — New Albany, Indiana, United States
• COAST Investigational Site — Lenexa, Kansas, United States
• COAST Investigational Site — Prairie Village, Kansas, United States
• COAST Investigational Site — West Monroe, Louisiana, United States
• COAST Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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