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

• Sponsor: Iconic Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02358889
• Collaborator: (none)
• Enrollment: 88
• Locations: 48
• Arms: 3
• Duration (Months): 19
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Choroidal Neovascularization; Age-related Macular Degeneration	Biological: hI-con1; Biological: ranibizumab; Other: Sham injection	Phase 2

Study Design

• Study Type: Interventional
• 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: Feb 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Biological: hI-con1; Intravitreal injection of hI-con1 0.3 mg; Other Names: human Immuno-conjugate 1 ; Other: Sham injection; No injection is given, a needleless syringe is used to mimic an injection.
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.	Biological: hI-con1; Intravitreal injection of hI-con1 0.3 mg; Other Names: human Immuno-conjugate 1 ; Biological: ranibizumab; Intravitreal injection of ranibizumab 0.5 mg; Other Names: Lucentis®
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.	Biological: ranibizumab; Intravitreal injection of ranibizumab 0.5 mg; Other Names: Lucentis® ; Other: Sham injection; No injection is given, a needleless syringe is used to mimic an injection.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 [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.

2. Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3 [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

1. Change From Baseline in BCVA in the Study Eye at Month 6 [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.

2. Change From Baseline in CST in the Study Eye at Month 6 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States	85020
2		Phoenix	Arizona	United States	85021
3		Arcadia	California	United States	91007
4		Beverly Hills	California	United States	90211
5		Campbell	California	United States	95008
6		Glendale	California	United States	91203
7		Laguna Hills	California	United States	92653
8		Mountain View	California	United States	94040
9		Palm Desert	California	United States	92260
10		Palo Alto	California	United States	94303
11		San Francisco	California	United States	94109
12		Santa Ana	California	United States	92705
13		Golden	Colorado	United States	80401
14		Boynton Beach	Florida	United States	33426
15		Fort Myers	Florida	United States	33907
16		Panama City	Florida	United States	32405
17		Sarasota	Florida	United States	34233
18		Stuart	Florida	United States	34994
19		Winter Haven	Florida	United States	33907
20		Augusta	Georgia	United States	30909
21		Paducah	Kentucky	United States	42001
22		Baltimore	Maryland	United States	21209
23		Boston	Massachusetts	United States	02111
24		Detroit	Michigan	United States	48072
25		Jackson	Michigan	United States	49202
26		Royal Oak	Michigan	United States	48073
27		West Bloomfield	Michigan	United States	48322
28		Minneapolis	Minnesota	United States	55435
29		Las Vegas	Nevada	United States	89144
30		Bloomfield	New Jersey	United States	07003
31		Brooklyn	New York	United States	11223
32		Hauppauge	New York	United States	11788
33		Syracuse	New York	United States	13224
34		Ashland	Oregon	United States	97520
35		Portland	Oregon	United States	97210
36		Huntingdon Valley	Pennsylvania	United States	19006
37		Philadelphia	Pennsylvania	United States	19107
38		West Columbia	South Carolina	United States	29169
39		Kingsport	Tennessee	United States	37660
40		Abilene	Texas	United States	79606
41		Austin	Texas	United States	78705
42		Houston	Texas	United States	77030
43		McAllen	Texas	United States	78503
44		San Antonio	Texas	United States	78240
45		The Woodlands	Texas	United States	77384
46		Salt Lake City	Utah	United States	84107
47		Silverdale	Washington	United States	98383
48		Madison	Wisconsin	United States	53705

Sponsors and Collaborators

• Iconic Therapeutics, Inc.

Investigators

• Study Director: Gabriela Burian, MD, Iconic Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iconic Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02358889
• Other Study ID Numbers: IT-002
• First Posted: Feb 9, 2015
• Last Update Posted: Sep 24, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Ranibizumab; Immunoconjugates

Study Results

Participant Flow

Arm/Group Title	hI-con1	hI-con1 + Ranibizumab	Ranibizumab
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg	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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
Period Title: Overall Study
STARTED	30	30	28
COMPLETED	30	28	27
NOT COMPLETED	0	2	1

Baseline Characteristics

Arm/Group Title	hI-con1	hI-con1 + Ranibizumab	Ranibizumab	Total
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg	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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	Total of all reporting groups
Overall Participants	30	30	28	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.4 (10.65)	78.4 (9.92)	78.8 (7.19)	77.1 (9.52)
Sex: Female, Male (Count of Participants)
Female	19 63.3%	17 56.7%	17 60.7%	53 60.2%
Male	11 36.7%	13 43.3%	11 39.3%	35 39.8%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	28 100%	88 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hI-con1	hI-con1 + Ranibizumab	Ranibizumab
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg	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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
Measure Participants	29	30	27
Mean (Standard Deviation) [Letters]	.3 (7.76)	6.8 (8.21)	7.6 (7.05)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hI-con1	hI-con1 + Ranibizumab	Ranibizumab
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg	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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
Measure Participants	29	30	27
Mean (Standard Deviation) [Microns]	53.9 (17.01)	66.3 (10.95)	64.9 (27)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hI-con1	hI-con1 + Ranibizumab	Ranibizumab
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg	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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
Measure Participants	29	30	27
Mean (Standard Deviation) [Letters]	-2.1 (8.05)	8.4 (10.14)	8.3 (9.10)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hI-con1	hI-con1 + Ranibizumab	Ranibizumab
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.	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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg	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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
Measure Participants	29	30	27
Mean (Standard Deviation) [Microns]	-35.7 (71.52)	-83.9 (71.52)	-91.4 (137.10)

Adverse Events

Arm/Group Title	hI-con1		hI-con1 + Ranibizumab		Ranibizumab
Arm/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. hI-con1: Intravitreal injection of hI-con1 0.3 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.		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. hI-con1: Intravitreal injection of hI-con1 0.3 mg ranibizumab: Intravitreal injection of ranibizumab 0.5 mg		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. ranibizumab: Intravitreal injection of ranibizumab 0.5 mg Sham injection: No injection is given, a needleless syringe is used to mimic an injection.
All Cause Mortality
	hI-con1		hI-con1 + Ranibizumab		Ranibizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/28 (0%)
Serious Adverse Events
	hI-con1		hI-con1 + Ranibizumab		Ranibizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/30 (10%)		1/30 (3.3%)		5/28 (17.9%)
Cardiac disorders
Atrial Fibrillation	1/30 (3.3%)	1	0/30 (0%)	0	0/28 (0%)	0
Myocardial Infarction	0/30 (0%)	0	1/30 (3.3%)	1	0/28 (0%)	0
Cardiac Failure	0/30 (0%)	0	0/30 (0%)	0	1/28 (3.6%)	1
General disorders
Vertigo Positional	1/30 (3.3%)	1	0/30 (0%)	0	0/28 (0%)	0
Infections and infestations
Pneumonia	1/30 (3.3%)	1	0/30 (0%)	0	3/28 (10.7%)	3
Cellulitis	1/30 (3.3%)	1	0/30 (0%)	0	0/28 (0%)	0
Pleural Effusion	1/30 (3.3%)	1	0/30 (0%)	0	0/28 (0%)	0
Subcutaneous abscess	1/30 (3.3%)	1	0/30 (0%)	0	0/28 (0%)	0
Sepsis	0/30 (0%)	0	0/30 (0%)	0	1/28 (3.6%)	1
Urinary Tract Infection	0/30 (0%)	0	0/30 (0%)	0	1/28 (3.6%)	1
Reproductive system and breast disorders
Prostate Cancer	0/30 (0%)	0	0/30 (0%)	0	1/28 (3.6%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	0/30 (0%)	0	0/30 (0%)	0	1/28 (3.6%)	1
Other (Not Including Serious) Adverse Events
	hI-con1		hI-con1 + Ranibizumab		Ranibizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/30 (70%)		26/30 (86.7%)		12/28 (42.9%)
Eye disorders
Conjunctival Haemorrhge	4/30 (13.3%)	4	8/30 (26.7%)	8	4/28 (14.3%)	4
Vitreous Floaters	4/30 (13.3%)	4	4/30 (13.3%)	4	3/28 (10.7%)	3
Eye Pain	1/30 (3.3%)	1	7/30 (23.3%)	7	1/28 (3.6%)	1
Retinal Haemorrhage	8/30 (26.7%)	8	1/30 (3.3%)	1	0/28 (0%)	0
Eye Irritation	2/30 (6.7%)	2	1/30 (3.3%)	1	0/28 (0%)	0
Vision Blurred	2/30 (6.7%)	2	1/30 (3.3%)	1	0/28 (0%)	0
Vitreous Detachment	0/30 (0%)	0	2/30 (6.7%)	2	2/28 (7.1%)	2
Blepharitis	0/30 (0%)	0	1/30 (3.3%)	1	2/28 (7.1%)	2
Conjunctival Oedema	0/30 (0%)	0	2/30 (6.7%)	2	0/28 (0%)	0
Punctate Keratitis	0/30 (0%)	0	2/30 (6.7%)	2	0/28 (0%)	0
Increased Intraocular Pressure	5/30 (16.7%)	5	2/30 (6.7%)	2	0/28 (0%)	0
Abnormal Visual Acuity Test	5/30 (16.7%)	5	2/30 (6.7%)	2	0/28 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.