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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Choroidal Neovascularization
- Sponsor
- Iconic Therapeutics, Inc.
- Enrollment
- 88
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Investigators
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)
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
Time Frame: Baseline and Month 3
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
Time Frame: Baseline and Month 3
Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.
Secondary Outcomes
- Change From Baseline in BCVA in the Study Eye at Month 6(Baseline and Month 6)
- Change From Baseline in CST in the Study Eye at Month 6(Baseline and Month 6)