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

Age-related Macular Degeneration Clinical Trial

— EMERGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358889
• Other study ID #: IT-002
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2020
• Source: Iconic Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Biological:
• hI-con1
Intravitreal injection of hI-con1 0.3 mg
• ranibizumab
Intravitreal injection of ranibizumab 0.5 mg

Other:
• Sham injection
No injection is given, a needleless syringe is used to mimic an injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iconic Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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