Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 12/3/2017 |
| Start Date: | February 2015 |
| End Date: | September 2016 |
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
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).
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).
Inclusion Criteria:
- Males or females of any race at least 50 years of age
- Active primary CNV secondary to AMD in the study eye
- 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)
We found this trial at
48
sites
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