Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (EMERGE)
Choroidal Neovascularization, Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for Choroidal Neovascularization
Eligibility Criteria
Inclusion Criteria:
- Males or females of any race at least 50 years of age
- Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye
- Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye
Exclusion Criteria:
- Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye
- Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
- Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
- Vitrectomy in the study eye
- Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
hI-con1
hI-con1 + ranibizumab
ranibizumab
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.