Status:
COMPLETED
A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
Lead Sponsor:
Opthea Limited
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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, o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2019
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT03345082
Start Date
November 6 2017
End Date
May 14 2019
Last Update
January 12 2021
Active Locations (108)
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1
Opthea Investigational Site
Phoenix, Arizona, United States, 85014
2
Opthea Investigational Site
Phoenix, Arizona, United States, 85020
3
Opthea Investigational Site
Beverly Hills, California, United States, 90211
4
Opthea Investigational Site
Encino, California, United States, 91436