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

Iconic Therapeutics

Status and phase: Completed; Phase 2

Conditions: Choroidal Neovascularization; Age-related Macular Degeneration

Treatments: Biological: ranibizumab; Other: Sham injection; Biological: hI-con1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02358889

IT-002

Details and patient eligibility

About

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).

Enrollment: 88 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

88 participants in 3 patient groups

hI-con1

Experimental group

Description:

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.

Treatment:

Biological: hI-con1

Other: Sham injection

hI-con1 + ranibizumab

Experimental group

Description:

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.

Treatment:

Biological: hI-con1

Biological: ranibizumab

ranibizumab

Active Comparator group

Description:

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.

Treatment:

Other: Sham injection

Biological: ranibizumab