A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Completed · Phase 2 · Has a placebo group

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Key facts

Study ID

NCT03345082

Run by

Opthea Limited

People needed

366

Starts

2017-11-06

Expected to finish

2019-05-14

Last updated by the study team

2021-01-12

Who can join

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

You may qualify if…

• Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
• An ETDRS BCVA score between 60 and 25 (inclusive) letters

You may not qualify if…

• Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
• Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
• Poorly controlled diabetes mellitus (defined as HbA1c>7%)
• Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study

Where it is running

• Opthea Investigational Site — Phoenix, Arizona, United States
• Opthea Investigational Site — Beverly Hills, California, United States
• Opthea Investigational Site — Encino, California, United States
• Opthea Investigational Site — Palm Desert, California, United States
• Opthea Investigational Site — Redlands, California, United States
• Opthea Study Site — Sacramento, California, United States
• Opthea Investigational Site — Sacramento, California, United States
• Opthea Investigational Site — San Diego, California, United States
• Opthea Investigational Site — Santa Ana, California, United States
• Opthea Investigational Site — Santa Barbara, California, United States
• Opthea Investigational Site — Santa Maria, California, United States
• Opthea Investigational Site — Colorado Springs, Colorado, United States
• Opthea Investigational Site — Golden, Colorado, United States
• Opthea Investigational Site — Boynton Beach, Florida, United States
• Opthea Investigational Site — Fort Myers, Florida, United States
• Opthea Investigational Site — Fort Myers, Florida, United States
• Opthea Investigational Site — Melbourne, Florida, United States
• Opthea Investigational Site — Pensacola, Florida, United States
• Opthea Investigational Site — St. Petersburg, Florida, United States
• Opthea Investigational Site — Tallahassee, Florida, United States
• Opthea Investigational Site — Winter Haven, Florida, United States
• Opthea Investigational Site — Augusta, Georgia, United States
• Opthea Investigational Site — Shawnee Mission, Kansas, United States
• Opthea Investigational Site — Wichita, Kansas, United States
• Opthea Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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