Study Evaluating Intravitreal hI-con1â„¢ 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-con1â„¢ 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: Yes
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
Professor of Ophthalmology (Ophthalmology Research/Clinical Trials) and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (MSD)
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