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

NCT02358889 | Completed Phase 2 Results

• 1 other identifier: IT-002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 48

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).

Conditions

Choroidal Neovascularization; Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change From Baseline in BCVA in the Study Eye at Month 6

  Baseline and Month 6

• Change From Baseline in CST in the Study Eye at Month 6

  Baseline and Month 6

Study Arms (3)

hI-con1

EXPERIMENTAL

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; Other: Sham injection

hI-con1 + ranibizumab

EXPERIMENTAL

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; Biological: ranibizumab

ranibizumab

ACTIVE COMPARATOR

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; Other: Sham injection

Interventions

hI-con1 BIOLOGICAL

Intravitreal injection of hI-con1 0.3 mg

Also known as: human Immuno-conjugate 1

hI-con1; hI-con1 + ranibizumab

ranibizumab BIOLOGICAL

Intravitreal injection of ranibizumab 0.5 mg

Also known as: Lucentis®

hI-con1 + ranibizumab; ranibizumab

Sham injection OTHER

No injection is given, a needleless syringe is used to mimic an injection.

hI-con1; ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Iconic Therapeutics, Inc.: lead

Study Sites (48)

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Phoenix, Arizona, 85020, United States

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Phoenix, Arizona, 85021, United States

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Arcadia, California, 91007, United States

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Beverly Hills, California, 90211, United States

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Campbell, California, 95008, United States

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Glendale, California, 91203, United States

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Laguna Hills, California, 92653, United States

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Mountain View, California, 94040, United States

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Palm Desert, California, 92260, United States

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Palo Alto, California, 94303, United States

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San Francisco, California, 94109, United States

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Santa Ana, California, 92705, United States

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Golden, Colorado, 80401, United States

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Boynton Beach, Florida, 33426, United States

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Fort Myers, Florida, 33907, United States

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Panama City, Florida, 32405, United States

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Sarasota, Florida, 34233, United States

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Stuart, Florida, 34994, United States

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Winter Haven, Florida, 33907, United States

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Augusta, Georgia, 30909, United States

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Paducah, Kentucky, 42001, United States

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Baltimore, Maryland, 21209, United States

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Boston, Massachusetts, 02111, United States

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Detroit, Michigan, 48072, United States

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Jackson, Michigan, 49202, United States

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Royal Oak, Michigan, 48073, United States

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West Bloomfield, Michigan, 48322, United States

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Minneapolis, Minnesota, 55435, United States

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Las Vegas, Nevada, 89144, United States

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Bloomfield, New Jersey, 07003, United States

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Brooklyn, New York, 11223, United States

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Hauppauge, New York, 11788, United States

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Syracuse, New York, 13224, United States

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Ashland, Oregon, 97520, United States

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Portland, Oregon, 97210, United States

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Huntingdon Valley, Pennsylvania, 19006, United States

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Philadelphia, Pennsylvania, 19107, United States

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West Columbia, South Carolina, 29169, United States

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Kingsport, Tennessee, 37660, United States

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Abilene, Texas, 79606, United States

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Austin, Texas, 78705, United States

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Houston, Texas, 77030, United States

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McAllen, Texas, 78503, United States

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San Antonio, Texas, 78240, United States

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The Woodlands, Texas, 77384, United States

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Salt Lake City, Utah, 84107, United States

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Silverdale, Washington, 98383, United States

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Madison, Wisconsin, 53705, United States

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MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

hI-con1; Ranibizumab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Gabriela Burian, M.D.
• Organization: Iconic Therapeutics

gburian@iconictherapeutics.com

6504371000

Study Officials

• Gabriela Burian, MD

  Iconic Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

US (48)