Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Study Overview
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Brief Summary
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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
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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

Conditions
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Choroidal Neovascularization, Age-related Macular Degeneration

Intervention / Treatment
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* Biological: hI-con1
* Biological: ranibizumab
* Other: Sham injection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hI-con1<br>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. | Biological: hI-con1<br>* Intravitreal injection of hI-con1 0.3 mg<br>* Other names: human Immuno-conjugate 1;Other: Sham injection<br>* No injection is given, a needleless syringe is used to mimic an injection.<br>|
| Experimental: hI-con1 + ranibizumab<br>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. | Biological: hI-con1<br>* Intravitreal injection of hI-con1 0.3 mg<br>* Other names: human Immuno-conjugate 1;Biological: ranibizumab<br>* Intravitreal injection of ranibizumab 0.5 mg<br>* Other names: Lucentis®;|
| Active Comparator: ranibizumab<br>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. | Biological: ranibizumab<br>* Intravitreal injection of ranibizumab 0.5 mg<br>* Other names: Lucentis®;Other: Sham injection<br>* No injection is given, a needleless syringe is used to mimic an injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at 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. | Baseline and Month 3 | 
| Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at 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. | Baseline and Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in BCVA in the Study Eye at Month 6 | 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. | Baseline and Month 6 | 
| Change From Baseline in CST in the Study Eye at Month 6 | Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement. | Baseline and Month 6 |