search
Back to results

Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease (PHOTON)

Primary Purpose

Diabetic Macular Edema, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
aflibercept
High-dose aflibercept
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diabetic macular edema (DME) with central involvement in the study eye
  • Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide informed consent signed by study participant or legally acceptable representative

Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.

Key Exclusion Criteria:

  • Evidence of macular edema due to any cause other than diabetes mellitus in either eye
  • Active proliferative diabetic retinopathy in the study eye
  • IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
  • Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
  • Treatment with ocriplasmin (JETREA®) in the study eye at any time

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Sites / Locations

  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site 1
  • Regeneron Study Site 2
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site 2
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site 1
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site 1
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

aflibercept Q8

High-Dose aflibercept Q12

High-Dose aflibercept Q16

Arm Description

Administered every 8 weeks after a loading phase

Administered every 12 weeks after a loading phase

Administered every 16 weeks after a loading phase

Outcomes

Primary Outcome Measures

Change from baseline in best corrected visual acuity (BCVA)

Secondary Outcome Measures

Proportion of participants with a ≥2 step improvement in Diabetic Retinopathy Severity Scale (DRSS)
The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.
Change from baseline in best corrected visual acuity (BCVA) (region-specific analysis)
Proportion of participants gaining ≥15 letters
Proportion of participants with BCVA ≥69 letters
Proportion of participants without fluid at foveal center
Change from baseline in central retinal thickness (CRT)
Proportion of participants without leakage on fluorescein angiography (FA)
Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score
Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
Systemic pharmacokinetics (PK) of aflibercept as assessed by plasma concentrations
Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response
Safety assessed by adverse events (AEs)
Safety assessed by serious adverse events (SAEs)
Change from baseline in BCVA for participants with both baseline and week 48 BCVA, in the analysis subset
Per SAP Version 2.0 Appendix 10.9 for US Only
Change from 8-weeks post initial treatment phase in BCVA for participants with both 8-weeks post initial treatment phase BCVA and week 48 BCVA, in the analysis subset
Per SAP Version 2.0 Appendix 10.9 for US Only

Full Information

First Posted
May 26, 2020
Last Updated
May 19, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT04429503
Brief Title
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Acronym
PHOTON
Official Title
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aflibercept Q8
Arm Type
Active Comparator
Arm Description
Administered every 8 weeks after a loading phase
Arm Title
High-Dose aflibercept Q12
Arm Type
Experimental
Arm Description
Administered every 12 weeks after a loading phase
Arm Title
High-Dose aflibercept Q16
Arm Type
Experimental
Arm Description
Administered every 16 weeks after a loading phase
Intervention Type
Drug
Intervention Name(s)
aflibercept
Other Intervention Name(s)
EYLEA®, BAY86-5321
Intervention Description
Intravitreally (IVT) administered as a liquid formulation in a vial
Intervention Type
Drug
Intervention Name(s)
High-dose aflibercept
Intervention Description
Intravitreally (IVT) administered as a liquid formulation in a vial
Primary Outcome Measure Information:
Title
Change from baseline in best corrected visual acuity (BCVA)
Time Frame
At Week 48
Secondary Outcome Measure Information:
Title
Proportion of participants with a ≥2 step improvement in Diabetic Retinopathy Severity Scale (DRSS)
Description
The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.
Time Frame
At Week 48
Title
Change from baseline in best corrected visual acuity (BCVA) (region-specific analysis)
Time Frame
At Week 60
Title
Proportion of participants gaining ≥15 letters
Time Frame
At Week 48
Title
Proportion of participants with BCVA ≥69 letters
Time Frame
At Week 48
Title
Proportion of participants without fluid at foveal center
Time Frame
At Week 48
Title
Change from baseline in central retinal thickness (CRT)
Time Frame
At Week 48
Title
Proportion of participants without leakage on fluorescein angiography (FA)
Time Frame
At Week 48
Title
Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score
Description
Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
Time Frame
At Week 48
Title
Systemic pharmacokinetics (PK) of aflibercept as assessed by plasma concentrations
Time Frame
Through Week 48
Title
Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response
Time Frame
Through Week 96
Title
Safety assessed by adverse events (AEs)
Time Frame
Through Weeks 48, 60, 96 and 156
Title
Safety assessed by serious adverse events (SAEs)
Time Frame
Through Weeks 48, 60, 96 and 156
Title
Change from baseline in BCVA for participants with both baseline and week 48 BCVA, in the analysis subset
Description
Per SAP Version 2.0 Appendix 10.9 for US Only
Time Frame
At Week 48
Title
Change from 8-weeks post initial treatment phase in BCVA for participants with both 8-weeks post initial treatment phase BCVA and week 48 BCVA, in the analysis subset
Description
Per SAP Version 2.0 Appendix 10.9 for US Only
Time Frame
At Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diabetic macular edema (DME) with central involvement in the study eye Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME Willing and able to comply with clinic visits and study-related procedures Provide informed consent signed by study participant or legally acceptable representative Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment. Key Exclusion Criteria: Evidence of macular edema due to any cause other than diabetes mellitus in either eye Active proliferative diabetic retinopathy in the study eye IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time Treatment with ocriplasmin (JETREA®) in the study eye at any time NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Regeneron Study Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
Regeneron Study Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Regeneron Study Site
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Regeneron Study Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Regeneron Study Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Regeneron Study Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Regeneron Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Regeneron Study Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Regeneron Study Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Regeneron Study Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Regeneron Study Site
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Regeneron Study Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Regeneron Study Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Regeneron Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Regeneron Study Site
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Regeneron Study Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Regeneron Study Site
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Regeneron Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Regeneron Study Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Regeneron Study Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Regeneron Study Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Regeneron Study Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Regeneron Study Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Regeneron Study Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Regeneron Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Regeneron Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Regeneron Study Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Regeneron Study Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Regeneron Study Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Regeneron Study Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Regeneron Study Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Regeneron Study Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Regeneron Study Site 1
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Regeneron Study Site 2
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Regeneron Study Site
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Regeneron Study Site
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Regeneron Study Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Regeneron Study Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Regeneron Study Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Regeneron Study Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Regeneron Study Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Regeneron Study Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Regeneron Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Regeneron Study Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Regeneron Study Site
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Regeneron Study Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Regeneron Study Site
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Regeneron Study Site
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Regeneron Study Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Regeneron Study Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Regeneron Study Site
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Regeneron Study Site
City
New York
State/Province
New York
ZIP/Postal Code
11221
Country
United States
Facility Name
Regeneron Study Site
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Regeneron Study Site
City
Shirley
State/Province
New York
ZIP/Postal Code
02114
Country
United States
Facility Name
Regeneron Study Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Regeneron Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Regeneron Study Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Regeneron Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Facility Name
Regeneron Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Regeneron Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Regeneron Study Site
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Regeneron Study Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Regeneron Study Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Regeneron Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Regeneron Study Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Regeneron Study Site
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Regeneron Study Site
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Regeneron Study Site
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Regeneron Study Site
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Regeneron Study Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Regeneron Study Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Regeneron Study Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Regeneron Study Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Regeneron Study Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Regeneron Study Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Regeneron Study Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Regeneron Study Site 2
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Regeneron Study Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Regeneron Study Site
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Regeneron Study Site 1
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Regeneron Study Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Regeneron Study Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Regeneron Study Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Regeneron Study Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
Facility Name
Regeneron Study Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
Facility Name
Regeneron Study Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3C 0G9
Country
Canada
Facility Name
Regeneron Study Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2V4
Country
Canada
Facility Name
Regeneron Study Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Regeneron Study Site
City
Prague 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Regeneron Study Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Regeneron Study Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Regeneron Study Site
City
Neubrandenburg
State/Province
Mecklenburg-Westfalen
ZIP/Postal Code
17036
Country
Germany
Facility Name
Regeneron Study Site
City
Gottingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Regeneron Study Site
City
Munster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Regeneron Study Site 1
City
Pecs
State/Province
Baranya
ZIP/Postal Code
H-7621
Country
Hungary
Facility Name
Regeneron Study Site
City
Szombathely
State/Province
Vas
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Regeneron Study Site
City
Zalaegerszeg
State/Province
Zala Megye
ZIP/Postal Code
H-8900
Country
Hungary
Facility Name
Regeneron Study Site
City
Budapest
ZIP/Postal Code
H-1085
Country
Hungary
Facility Name
Regeneron Study Site
City
Budapest
ZIP/Postal Code
H-1106
Country
Hungary
Facility Name
Regeneron Study Site
City
Budapest
ZIP/Postal Code
H-1133
Country
Hungary
Facility Name
Regeneron Study Site
City
Budapest
ZIP/Postal Code
H-1145
Country
Hungary
Facility Name
Regeneron Study Site
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Regeneron Study Site
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Regeneron Study Site
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Regeneron Study Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Regeneron Study Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Regeneron Study Site
City
Yoshida-Gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Regeneron Study Site
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Regeneron Study Site
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
Regeneron Study Site
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
041-0851
Country
Japan
Facility Name
Regeneron Study Site
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Regeneron Study Site
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0845
Country
Japan
Facility Name
Regeneron Study Site
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0014
Country
Japan
Facility Name
Regeneron Study Site
City
Tsuchiura-shi
State/Province
Ibaraki
ZIP/Postal Code
300-0817
Country
Japan
Facility Name
Regeneron Study Site
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Regeneron Study Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Regeneron Study Site
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Regeneron Study Site
City
Nagasaki City
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Regeneron Study Site
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Regeneron Study Site
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Regeneron Study Site
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Regeneron Study Site
City
Susono
State/Province
Shizuoka
ZIP/Postal Code
410-1102
Country
Japan
Facility Name
Regeneron Study Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Regeneron Study Site
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Regeneron Study Site
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Facility Name
Regeneron Study Site
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Regeneron Study Site
City
Shimotsuke-shi
State/Province
Totigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Regeneron Study Site
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Regeneron Study Site
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan
Facility Name
Regeneron Study Site
City
Fukuoka
ZIP/Postal Code
819-8585
Country
Japan
Facility Name
Regeneron Study Site
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Regeneron Study Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Regeneron Study Site
City
Saitama
ZIP/Postal Code
330-8553
Country
Japan
Facility Name
Regeneron Study Site
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Regeneron Study Site
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Regeneron Study Site
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
Facility Name
Regeneron Study Site
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
IPD Sharing Access Criteria
Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
IPD Sharing URL
https://vivli.org/

Learn more about this trial

Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

We'll reach out to this number within 24 hrs