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

Phase 2

Completed

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, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Primary Outcome Measures

Name	Time	Method
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)	Baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)	Baseline to Week 24
Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)	Baseline to Week 24
Proportion of participants gaining 15 or more ETDRS BCVA letters	Baseline to Week 24
Area under the ETDRS BCVA over time curve	Baseline to Week 24
Change in intra-retinal fluid and sub-retinal fluid on SD-OCT	Baseline to Week 24

Locations (3): Opthea Investigational Site
🇬🇧
Wolverhampton, United Kingdom
Opthea Study Site
🇺🇸
Sacramento, California, United States
Opthea Investigationa Site
🇵🇱
Lublin, Poland
Opthea Investigational Site
🇬🇧Wolverhampton, United Kingdom