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Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD (MAKO)

Primary Purpose

Age-related Macular Degeneration

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Squalamine lactate ophthalmic solution, 0.2%
Placebo Ophthalmic solution
ranibizumab
Sponsored by
Ohr Pharmaceutical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring AMD, CNV, choroidal neovascularization, retinal eye disease

Eligibility Criteria

50 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 50 years
  • A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA)
  • Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
  • Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart)

Exclusion Criteria:

  • Neovascularization secondary to any other condition than AMD in the study eye; Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea
  • Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes
  • Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
  • Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
  • Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Squalamine solution, 0.2% BID

Placebo solution BID

Arm Description

Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks

Placebo ophthalmic solution BID + ranibizumab every 4 weeks

Outcomes

Primary Outcome Measures

Functional change in visual acuity
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration

Secondary Outcome Measures

Functional changes in visual acuity
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration

Full Information

First Posted
March 28, 2016
Last Updated
April 25, 2017
Sponsor
Ohr Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02727881
Brief Title
Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD
Acronym
MAKO
Official Title
OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohr Pharmaceutical Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint
Detailed Description
Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months (Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio: Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
AMD, CNV, choroidal neovascularization, retinal eye disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Squalamine solution, 0.2% BID
Arm Type
Experimental
Arm Description
Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
Arm Title
Placebo solution BID
Arm Type
Placebo Comparator
Arm Description
Placebo ophthalmic solution BID + ranibizumab every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Squalamine lactate ophthalmic solution, 0.2%
Other Intervention Name(s)
active
Intervention Description
Squalamine lactate ophthalmic solution, 0.2%
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic solution
Other Intervention Name(s)
placebo
Intervention Description
Placebo Ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
ranibizumab
Primary Outcome Measure Information:
Title
Functional change in visual acuity
Description
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Functional changes in visual acuity
Description
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Treatment emergent Adverse Event (AE) monitoring
Description
Adverse and Serious Adverse Events in subjects receiving combination therapy of ranibizumab intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% assessed by adverse event reporting and Ophthalmic examinations
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 50 years A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA) Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart) Exclusion Criteria: Neovascularization secondary to any other condition than AMD in the study eye; Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease) Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Ingerman, MD
Organizational Affiliation
Ohr Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
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United States
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Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
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United States
Facility Name
Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
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United States
Facility Name
Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
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United States
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Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
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United States
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Investigational Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
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United States
Facility Name
Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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United States
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Investigational Site
City
Campbell
State/Province
California
ZIP/Postal Code
95008
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United States
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Investigational Site
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Fullerton
State/Province
California
ZIP/Postal Code
92835
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United States
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Investigational Site
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Glendale
State/Province
California
ZIP/Postal Code
91203
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United States
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Investigational Site
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Glendora
State/Province
California
ZIP/Postal Code
91741
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United States
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Investigational Site
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La Jolla
State/Province
California
ZIP/Postal Code
92093
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United States
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Investigational Site
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Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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United States
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Investigational Site
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Loma Linda
State/Province
California
ZIP/Postal Code
92354
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United States
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Investigational Site
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Los Angeles
State/Province
California
ZIP/Postal Code
90017
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United States
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Investigational Site
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Oceanside
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California
ZIP/Postal Code
92056
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United States
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Orange
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California
ZIP/Postal Code
92868
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United States
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Palm Desert
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California
ZIP/Postal Code
92260
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United States
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Palo Alto
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California
ZIP/Postal Code
94303
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United States
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Investigational Site
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Pasadena
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California
ZIP/Postal Code
91107
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United States
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Poway
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California
ZIP/Postal Code
92064
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United States
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Redlands
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California
ZIP/Postal Code
92374
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United States
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Sacramento
State/Province
California
ZIP/Postal Code
91007
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United States
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Investigational Site
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Bridgeport
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Connecticut
ZIP/Postal Code
06606
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United States
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Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
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United States
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New London
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Connecticut
ZIP/Postal Code
06320
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United States
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Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
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United States
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Investigational Site
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Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
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United States
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Investigational Site
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Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
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United States
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Miami
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Florida
ZIP/Postal Code
33136
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United States
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Miami
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Florida
ZIP/Postal Code
33143
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United States
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Naples
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Florida
ZIP/Postal Code
34103
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United States
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Sarasota
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Florida
ZIP/Postal Code
34233
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United States
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Stuart
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Florida
ZIP/Postal Code
34994
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United States
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Augusta
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Georgia
ZIP/Postal Code
30909
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United States
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'Aiea
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Hawaii
ZIP/Postal Code
96701
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United States
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Berwyn
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Illinois
ZIP/Postal Code
60402
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United States
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Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
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United States
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Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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United States
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Sycamore
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Illinois
ZIP/Postal Code
60178
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United States
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New Albany
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Indiana
ZIP/Postal Code
47150
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United States
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Leawood
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Kansas
ZIP/Postal Code
66211
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United States
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Louisville
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Kentucky
ZIP/Postal Code
40202
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United States
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Paducah
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Kentucky
ZIP/Postal Code
42001
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United States
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Portland
State/Province
Maine
ZIP/Postal Code
04102
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21209
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21237
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United States
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Glen Burnie
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Maryland
ZIP/Postal Code
21061
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United States
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Hagerstown
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Maryland
ZIP/Postal Code
21740
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United States
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Pikesville
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Maryland
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21208
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United States
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Rockville
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Maryland
ZIP/Postal Code
20877
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United States
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Detroit
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Michigan
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48201
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United States
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Grand Rapids
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Michigan
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49546
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United States
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Jackson
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Michigan
ZIP/Postal Code
49202
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United States
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Royal Oak
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Michigan
ZIP/Postal Code
48073
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United States
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Southfield
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Michigan
ZIP/Postal Code
48304
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United States
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Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
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United States
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Investigational Site
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Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
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United States
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Investigational Site
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Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
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United States
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Investigational Site
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Florissant
State/Province
Missouri
ZIP/Postal Code
63031
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United States
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Investigational Site
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Henderson
State/Province
Nevada
ZIP/Postal Code
89052
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United States
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Investigational Site
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Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
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United States
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Investigational Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
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United States
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Investigational Site
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
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United States
Facility Name
Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
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United States
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Investigational Site
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New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
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United States
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Investigational Site
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Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
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United States
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Investigational Site
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Ramsey
State/Province
New Jersey
ZIP/Postal Code
07446
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United States
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Investigational Site
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Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
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United States
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Investigational Site
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Toms River
State/Province
New Jersey
ZIP/Postal Code
07083
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United States
Facility Name
Investigational Site
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Brooklyn
State/Province
New York
ZIP/Postal Code
11223
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United States
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Investigational Site
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Great Neck
State/Province
New York
ZIP/Postal Code
11021
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United States
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Investigational Site
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Hauppauge
State/Province
New York
ZIP/Postal Code
11788
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United States
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Investigational Site
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Lynbrook
State/Province
New York
ZIP/Postal Code
11563
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United States
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Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
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United States
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Investigational Site
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New York
State/Province
New York
ZIP/Postal Code
10032
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United States
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Investigational Site
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Rochester
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New York
ZIP/Postal Code
14620
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United States
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Investigational Site
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Rockville Centre
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New York
ZIP/Postal Code
11570
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United States
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Syracuse
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New York
ZIP/Postal Code
13224
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United States
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Charlotte
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North Carolina
ZIP/Postal Code
28210
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United States
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Concord
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North Carolina
ZIP/Postal Code
28025
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United States
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Cleveland
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Ohio
ZIP/Postal Code
44122
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United States
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Cleveland
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Ohio
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44130
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United States
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Cleveland
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Ohio
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44195
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United States
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Toledo
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Ohio
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43615
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United States
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Youngstown
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Ohio
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44505
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United States
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Ashland
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Oregon
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97520
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United States
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Camp Hill
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Pennsylvania
ZIP/Postal Code
17011
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United States
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Kingston
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Pennsylvania
ZIP/Postal Code
18704
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United States
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Investigational Site
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Lancaster
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Pennsylvania
ZIP/Postal Code
17601
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United States
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Investigational Site
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Philadelphia
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Pennsylvania
ZIP/Postal Code
19104
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United States
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Investigational Site
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
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United States
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Investigational Site
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19116
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United States
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Investigational Site
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
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United States
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Investigational Site
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Columbia
State/Province
South Carolina
ZIP/Postal Code
29223
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United States
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Investigational Site
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Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
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United States
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Investigational Site
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Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
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United States
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Investigational Site
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Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
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United States
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Investigational Site
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Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
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United States
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Investigational Site
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Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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United States
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Investigational Site
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Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
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United States
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Investigational Site
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Grapevine
State/Province
Texas
ZIP/Postal Code
76051
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United States
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Investigational Site
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Harlingen
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Texas
ZIP/Postal Code
78550
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United States
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Investigational Site
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Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
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Investigational Site
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Katy
State/Province
Texas
ZIP/Postal Code
77494
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United States
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Investigational Site
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Kingwood
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Texas
ZIP/Postal Code
77339
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United States
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McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Investigational Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Investigational Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Investigational Site
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Facility Name
Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

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