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

Phase 2

Completed

• Conditions: Age-related Macular Degeneration; Choroidal Neovascularization
• Interventions: Biological: hI-con1; Biological: ranibizumab; Other: Sham injection

• Registration Number: NCT02358889
• Lead Sponsor: Iconic Therapeutics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Disposition First Submitted: 2017-11-28
• Disposition First Submitted QC: 2017-11-28
• Disposition First Posted: 2017-12-02
• Results First Submitted: 2020-08-12
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Results First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hI-con1	Sham injection	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.
hI-con1	hI-con1	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.
ranibizumab	Sham injection	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.
hI-con1 + ranibizumab	hI-con1	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.
ranibizumab	ranibizumab	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.
hI-con1 + ranibizumab	ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in BCVA in the Study Eye at Month 6	Baseline and 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.
Change From Baseline in CST in the Study Eye at Month 6	Baseline and 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.