Phase 2 N=88 Randomized Triple-blind Treatment

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

Choroidal Neovascularization · Age-related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02358889 ↗

Enrolled (actual)

Serious AEs

10.2%

Results posted

Sep 2020

Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 — .3; 6.8; 7.6 Letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: hI-con1 (Biological); ranibizumab (Biological); Sham injection (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Iconic Therapeutics, Inc.
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3	.3; 6.8; 7.6	—
PRIMARY Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3	53.9; 66.3; 64.9	—
SECONDARY Change From Baseline in BCVA in the Study Eye at Month 6	-2.1; 8.4; 8.3	—
SECONDARY Change From Baseline in CST in the Study Eye at Month 6	-35.7; -83.9; -91.4	—

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).

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02358889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.