search
Back to results

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

Primary Purpose

Choroidal Neovascularization, Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hI-con1
ranibizumab
Sham injection
Sponsored by
Iconic Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

hI-con1

hI-con1 + ranibizumab

ranibizumab

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 4, 2015
Last Updated
September 23, 2020
Sponsor
Iconic Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02358889
Brief Title
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iconic Therapeutics, Inc.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hI-con1
Arm Type
Experimental
Arm 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.
Arm Title
hI-con1 + ranibizumab
Arm Type
Experimental
Arm 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.
Arm Title
ranibizumab
Arm Type
Active Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
hI-con1
Other Intervention Name(s)
human Immuno-conjugate 1
Intervention Description
Intravitreal injection of hI-con1 0.3 mg
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Intravitreal injection of ranibizumab 0.5 mg
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
No injection is given, a needleless syringe is used to mimic an injection.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
Description
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.
Time Frame
Baseline and Month 3
Secondary Outcome Measure Information:
Title
Change From Baseline in BCVA in the Study Eye at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change From Baseline in CST in the Study Eye at Month 6
Description
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.
Time Frame
Baseline and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela Burian, MD
Organizational Affiliation
Iconic Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11223
Country
United States
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs