Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Trial ID or NCT#
NCT02358889
Status
NOT RECRUITING
Purpose
The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Official Title
A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Eligibility Criteria
Ages Eligible for Study: Older than 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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)
Investigator(s)
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
View on ClinicalTrials.gov
