Neovascular Age-related Macular Degeneration (wet AMD)
Conditions
Brief summary
Mean change from Baseline to Week 52 in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters.
Detailed description
Efficacy: - Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52 - Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52, - Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52 - Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52
Interventions
Sponsors
Opthea Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from Baseline to Week 52 in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: - Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52 - Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52, - Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52 - Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52 | — |
Countries
Austria, Bulgaria, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Slovakia, Spain
Outcome results
None listed