Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (EMERGE)
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| ClinicalTrials.gov Identifier: NCT02358889 |
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Recruitment Status :
Completed
First Posted : February 9, 2015
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
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Sponsor:
Iconic Therapeutics, Inc.
Information provided by (Responsible Party):
Iconic Therapeutics, Inc.
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Choroidal Neovascularization Age-related Macular Degeneration | Biological: hI-con1 Biological: ranibizumab Other: Sham injection | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | February 2015 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | September 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Biological: hI-con1
Intravitreal injection of hI-con1 0.3 mg
Other Name: human Immuno-conjugate 1 Other: Sham injection No injection is given, a needleless syringe is used to mimic an injection. |
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Experimental: hI-con1 + 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.
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Biological: hI-con1
Intravitreal injection of hI-con1 0.3 mg
Other Name: human Immuno-conjugate 1 Biological: ranibizumab Intravitreal injection of ranibizumab 0.5 mg
Other Name: Lucentis® |
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Active Comparator: 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.
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Biological: ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Other Name: Lucentis® Other: Sham injection No injection is given, a needleless syringe is used to mimic an injection. |
Primary Outcome Measures :
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 [ Time Frame: 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 [ Time Frame: 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 :
- Change From Baseline in BCVA in the Study Eye at Month 6 [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358889
Locations
| United States, Arizona | |
| Phoenix, Arizona, United States, 85020 | |
| Phoenix, Arizona, United States, 85021 | |
| United States, California | |
| Arcadia, California, United States, 91007 | |
| Beverly Hills, California, United States, 90211 | |
| Campbell, California, United States, 95008 | |
| Glendale, California, United States, 91203 | |
| Laguna Hills, California, United States, 92653 | |
| Mountain View, California, United States, 94040 | |
| Palm Desert, California, United States, 92260 | |
| Palo Alto, California, United States, 94303 | |
| San Francisco, California, United States, 94109 | |
| Santa Ana, California, United States, 92705 | |
| United States, Colorado | |
| Golden, Colorado, United States, 80401 | |
| United States, Florida | |
| Boynton Beach, Florida, United States, 33426 | |
| Fort Myers, Florida, United States, 33907 | |
| Panama City, Florida, United States, 32405 | |
| Sarasota, Florida, United States, 34233 | |
| Stuart, Florida, United States, 34994 | |
| Winter Haven, Florida, United States, 33907 | |
| United States, Georgia | |
| Augusta, Georgia, United States, 30909 | |
| United States, Kentucky | |
| Paducah, Kentucky, United States, 42001 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21209 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48072 | |
| Jackson, Michigan, United States, 49202 | |
| Royal Oak, Michigan, United States, 48073 | |
| West Bloomfield, Michigan, United States, 48322 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55435 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89144 | |
| United States, New Jersey | |
| Bloomfield, New Jersey, United States, 07003 | |
| United States, New York | |
| Brooklyn, New York, United States, 11223 | |
| Hauppauge, New York, United States, 11788 | |
| Syracuse, New York, United States, 13224 | |
| United States, Oregon | |
| Ashland, Oregon, United States, 97520 | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Huntingdon Valley, Pennsylvania, United States, 19006 | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Abilene, Texas, United States, 79606 | |
| Austin, Texas, United States, 78705 | |
| Houston, Texas, United States, 77030 | |
| McAllen, Texas, United States, 78503 | |
| San Antonio, Texas, United States, 78240 | |
| The Woodlands, Texas, United States, 77384 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Washington | |
| Silverdale, Washington, United States, 98383 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
Sponsors and Collaborators
Iconic Therapeutics, Inc.
Investigators
| Study Director: | Gabriela Burian, MD | Iconic Therapeutics, Inc. |
| Responsible Party: | Iconic Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02358889 |
| Other Study ID Numbers: |
IT-002 |
| First Posted: | February 9, 2015 Key Record Dates |
| Results First Posted: | September 24, 2020 |
| Last Update Posted: | September 24, 2020 |
| Last Verified: | September 2020 |
Additional relevant MeSH terms:
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Macular Degeneration Choroidal Neovascularization Neovascularization, Pathologic Retinal Degeneration Retinal Diseases Eye Diseases Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases |
Ranibizumab Immunoconjugates Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunologic Factors |