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Fenofibrate for Prevention of DR Worsening (Protocol AF)

Primary Purpose

Diabetic Retinopathy

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate
Placebo
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Fenofibrate, non-proliferative diabetic retinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

  • Age ≥18 years and < 80 years.
  • Type 1 or type 2 diabetes.

  • At least one eye with the following:

    • Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.
    • Best-corrected E-ETDRS visual acuity letter score of ≥79 (approximate Snellen equivalent 20/25 or better).
  • If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)

Key Exclusion Criteria

Eye-level exclusion criteria (the eye is ineligible if any of the following is met):

  • Current CI-DME based on clinical exam or OCT central subfield thickness (CST)

    • Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men
    • Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men
  • Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
  • History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication

Participant-level exclusion criterion (the participant is ineligible if the following criterion is met):

• Decreased renal function, defined as requiring dialysis or central laboratory eGFR value < 45 mL/min/1.73 m2

Sites / Locations

  • Kent W. Small, MD, AMCRecruiting
  • Salehi Retina Institute Inc.Recruiting
  • Loma Linda UniversityRecruiting
  • Regents of the University of California, Davis, DBA University of California, DavisRecruiting
  • The Regents of the University of California, San FranciscoRecruiting
  • National Ophthalmic Research InstituteRecruiting
  • University of Florida- JacksonvilleRecruiting
  • Florida Retina Institute, James A. Staman, MD, PA- JacksonvilleRecruiting
  • Florida Retina ConsultantsRecruiting
  • Florida Retina Institute, James A. Staman, MD, PA- OrlandoRecruiting
  • Retina Vitreous Consultants, LLPRecruiting
  • Sarasota Retina InstituteRecruiting
  • SEASHORE RETINA LLC DBA Retina Specialists of TampaRecruiting
  • Southeast Retina Center, P.C.Recruiting
  • Marietta Eye ClinicRecruiting
  • Thomas Eye GroupRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • Illinois Retina Associates SC - Oak Park SiteRecruiting
  • Midwest Eye InstituteRecruiting
  • John Kenyon American Eye Institute, LLCRecruiting
  • Wolfe Eye Clinic-Cedar RapidsRecruiting
  • Wolfe Clinic, P.C.- West Des MoinesRecruiting
  • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast LouisianaRecruiting
  • Elman Retina Group, P.A.Recruiting
  • Valley Eye Physicians and SurgeonsRecruiting
  • Boston Medical Center CorporationRecruiting
  • Joslin Diabetes CenterRecruiting
  • Henry Ford Health SystemRecruiting
  • Foundation for Vision Research and Retina Specialists of Michigan, P.C.Recruiting
  • Vitreo-Retinal AssociatesRecruiting
  • Retina Center, PA DBA Retina Center of MinnesotaRecruiting
  • Mayo ClinicRecruiting
  • The Curators of the University of MissouriRecruiting
  • Retina Research Institute, LLCRecruiting
  • Retina-Vitreous Surgeons of Central NY, PCRecruiting
  • MaculaCareRecruiting
  • Retina Associates of Western NY, P.C.Recruiting
  • Pamela Weber, MD/Island RetinaRecruiting
  • University of North Carolina at Chapel HillRecruiting
  • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of MedicineRecruiting
  • Dean A. McGee Eye InstituteRecruiting
  • Verum Research LLCRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Retina Consultants, LLCRecruiting
  • Cascade Medical Research Institute, LLCRecruiting
  • Retina-Vitreous Consultants, Inc.Recruiting
  • Pittsburg Clinical Trial ConsortiumRecruiting
  • Southeastern Retina Associates, P.C.Recruiting
  • Austin Research Center for RetinaRecruiting
  • Austin Retina AssociatesRecruiting
  • Retina Consultants of Texas, PARecruiting
  • Baylor College of Medicine, Baylor Eye Physicians and SurgeonsRecruiting
  • Texas Retina AssociatesRecruiting
  • Retinal Consultants of San AntonioRecruiting
  • Gunderson Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fenofibrate 160-mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Worsening of diabetic retinopathy
Defined as 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs. Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography. Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.

Secondary Outcome Measures

Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
Development of CI-DME
Defined as, either 1) at least a 10% increase in OCT central subfield thickness from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), and Investigator determination that thickening cannot be attributed to any cause other than CI-DME, or 2)Intraocular DME treatment including focal/grid laser, intraocular anti-VEGF, intraocular corticosteroid, or vitrectomy
Development of center-involved diabetic macular edema with vision loss
Defined as either 1) an increase in OCT central subfield thickness of 10% or more from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), investigator determination that thickening cannot be attributed to any cause other than DME, and a decrease in visual acuity from baseline of 10 or more letters at a single visit or 5 to 9 letters at 2 consecutive visits at least 21 days apart with vision loss presumed to be from DME, intraocular DME or 2) treatment including focal/grid laser, anti-VEGF, corticosteroid injection, or vitrectomy
Visual acuity loss from any cause
Defined as a decrease in visual acuity from baseline of 10 or more letters at a single visit or a 5 to 9-letter decrease at 2 consecutive visits at least 21 days apart regardless of whether vision loss is presumed to be from DME or any other cause

Full Information

First Posted
December 3, 2020
Last Updated
June 15, 2023
Sponsor
Jaeb Center for Health Research
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation, Roche Pharma AG, The Leona M. and Harry B. Helmsley Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04661358
Brief Title
Fenofibrate for Prevention of DR Worsening
Acronym
Protocol AF
Official Title
A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation, Roche Pharma AG, The Leona M. and Harry B. Helmsley Charitable Trust

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
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 4 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Fenofibrate, non-proliferative diabetic retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-masked, placebo-controlled clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
910 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fenofibrate 160-mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Description
Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
Primary Outcome Measure Information:
Title
Worsening of diabetic retinopathy
Description
Defined as 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs. Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography. Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.
Time Frame
4- years
Secondary Outcome Measure Information:
Title
Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
Time Frame
4 years
Title
Development of CI-DME
Description
Defined as, either 1) at least a 10% increase in OCT central subfield thickness from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), and Investigator determination that thickening cannot be attributed to any cause other than CI-DME, or 2)Intraocular DME treatment including focal/grid laser, intraocular anti-VEGF, intraocular corticosteroid, or vitrectomy
Time Frame
4 years
Title
Development of center-involved diabetic macular edema with vision loss
Description
Defined as either 1) an increase in OCT central subfield thickness of 10% or more from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), investigator determination that thickening cannot be attributed to any cause other than DME, and a decrease in visual acuity from baseline of 10 or more letters at a single visit or 5 to 9 letters at 2 consecutive visits at least 21 days apart with vision loss presumed to be from DME, intraocular DME or 2) treatment including focal/grid laser, anti-VEGF, corticosteroid injection, or vitrectomy
Time Frame
4 years
Title
Visual acuity loss from any cause
Description
Defined as a decrease in visual acuity from baseline of 10 or more letters at a single visit or a 5 to 9-letter decrease at 2 consecutive visits at least 21 days apart regardless of whether vision loss is presumed to be from DME or any other cause
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Age ≥18 years and < 80 years. Type 1 or type 2 diabetes. At least one eye with the following: Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs. Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study. If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20) Key Exclusion Criteria Eye-level exclusion criteria (the eye is ineligible if any of the following is met): Current CI-DME based on clinical exam or OCT central subfield thickness (CST) Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior. History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication Participant-level exclusion criterion (the participant is ineligible if the following criterion is met): • Decreased renal function, defined as requiring dialysis or central laboratory eGFR value < 45 mL/min/1.73 m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam R Glassman, MS
Phone
813-975-8690
Email
drcrnet@jaeb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Chew, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Y Chew, MD
Organizational Affiliation
National Institutes of Health (NIH)
Official's Role
Study Chair
Facility Information:
Facility Name
Kent W. Small, MD, AMC
City
Glendale
State/Province
California
ZIP/Postal Code
91203-1971
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kent W Small, MD, AMC
Phone
818-552-5040
Email
shayafadi@gmail.com
Facility Name
Salehi Retina Institute Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647-8693
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hani Salehi-Had, MD
Phone
657-227-9496
Email
y.ramirez@retinasocal.com
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David I. Sierpina, MD
Phone
909-558-2169
Email
nborntrager@llu.edu
Facility Name
Regents of the University of California, Davis, DBA University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ala Moshiri, MD, PhD
Phone
916-734-6974
Email
clwallace@ucdavis.edu
Facility Name
The Regents of the University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay M. Stewart, MD
Phone
415-206-3123
Email
daphne.yang@ucsf.edu
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avtar T Ghuman, MD
Phone
239-939-4323
Email
eileenk@eye.md
Facility Name
University of Florida- Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Grover, MD
Phone
904-244-9361
Email
ghulam.hamdani@jax.ufl.edu
Facility Name
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin J Thomas, MD
Phone
904-997-9202
Email
kareny@floridaretinainstitute.com
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott M. Friedman, MD
Phone
863-682-7474
Email
Dfagan@frc2020.com
Facility Name
Florida Retina Institute, James A. Staman, MD, PA- Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew A. Cunningham, MD
Phone
407-849-9621
Email
marthah@floridaretinainstitute.com
Facility Name
Retina Vitreous Consultants, LLP
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233-1261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John H. Niffeneger, MD
Phone
941-924-0303
Email
dscully@retinasarasota.com
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc H Levy, MD, FACS
Phone
941-921-5335
Email
srqresearch@aol.com
Facility Name
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
City
Wesley Chapel
State/Province
Florida
ZIP/Postal Code
33544
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad B. Tarabishy, MD
Email
smorris@retinacaretampa.com
Facility Name
Southeast Retina Center, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis M. Marcus, MD
Phone
706-650-0061
Email
daisy@southeastretina.com
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annal D Meleth, MD, MS
Phone
678-803-2600
Email
cnkemka@mariettaeye.com
Facility Name
Thomas Eye Group
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul L. Kaufman, MD
Phone
404-256-1507
Email
kathyw@thomaseye.com
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Lyon, MD
Phone
312-695-2567
Email
rachel.moore@northwestern.edu
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew W. MacCumber, PhD, MD
Phone
312-942-2117
Email
Manaal_pandit@rush.edu
Facility Name
Illinois Retina Associates SC - Oak Park Site
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew W MacCumber, MD, PhD
Phone
708-660-8450
Email
saraw@illinoisretina.com
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj K Maturi, MD, P.C.
Phone
317-817-1414
Email
rmaturi@gmail.com
Facility Name
John Kenyon American Eye Institute, LLC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Lazarus, MD
Phone
800-965-3937
Email
ldavis@johnkenyon.com
Facility Name
Wolfe Eye Clinic-Cedar Rapids
City
Hiawatha
State/Province
Iowa
ZIP/Postal Code
52233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul S Boeke, MD
Phone
319-362-8032
Email
plee@wolfeclinic.com
Facility Name
Wolfe Clinic, P.C.- West Des Moines
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-7705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared S Nielsen, MD
Phone
515-223-8685
Email
twoehl@wolfeclinic.com
Facility Name
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291-4452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben A. Grigorian, MD
Phone
318-325-2610
Email
sdavid@eyenela.com
Facility Name
Elman Retina Group, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J. Elman, MD
Phone
410-686-3000
Email
Starr@elmanretina.com
Facility Name
Valley Eye Physicians and Surgeons
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisela Velez, MD, MPH, MA
Phone
978-772-4000
Email
research@valleyeyephysicians.com
Facility Name
Boston Medical Center Corporation
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven D. Ness, MD
Phone
617-414-4020
Email
sreevardhan.alluri@bmc.org
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George S Sharuk, MD
Phone
617-309-2520
Email
Ann.Kopple@joslin.harvard.edu
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A Edwards, MD
Phone
313-874-9167
Email
drush1@hfhs.org
Facility Name
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas M. Aaberg, MD
Phone
616-954-2020
Email
holly@fvr.org
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis C Glazer, MD
Phone
616-285-1200
Email
carlasmith@vrapc.com
Facility Name
Retina Center, PA DBA Retina Center of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdhish R Bhavsar, MD
Phone
612-871-2292
Email
agilchrist@retinadocs.com
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew J. Barkmeier, MD
Phone
507-538-8119
Email
wernimont.suzanne@mayo.edu
Facility Name
The Curators of the University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201-5276
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M. Elkeeb, MD
Phone
573-882-1506
Email
waltonba@health.missouri.edu
Facility Name
Retina Research Institute, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128-1729
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alia K. Durrani, MD
Phone
314-367-1181
Email
rhonda.weeks@rc-stl.com
Facility Name
Retina-Vitreous Surgeons of Central NY, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin I. Rosenberg
Phone
315-445-8166
Email
lsienkiewycz@rvscny.com
Facility Name
MaculaCare
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel F. Rosberger, MD, PhD, MPH
Phone
212-439-9600
Email
phuntsho@maculacare.com
Facility Name
Retina Associates of Western NY, P.C.
City
Rochester
State/Province
New York
ZIP/Postal Code
14620-4655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew T Witmer, MD
Phone
585-442-3411
Email
myagoda@retinaassociatesofwny.com
Facility Name
Pamela Weber, MD/Island Retina
City
Shirley
State/Province
New York
ZIP/Postal Code
11967
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Weber, MD, PC
Phone
631-924-4300
Email
lswain@island-retina.com
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan N. Ulrich, MD
Phone
919-966-5296
Email
elizabeth_dubose@med.unc.edu
Facility Name
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra V. Rachitskaya, MD
Phone
216-445-9519
Email
contit@ccf.org
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald M. Kingsley, MD
Phone
405-271-6307
Email
Alisha-Brewer@dmei.org
Facility Name
Verum Research LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert O. Edwards, MD, PhD
Phone
541-762-2763
Email
lcarroll@oregonretina.org
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merina Thomas, MD
Phone
503-494-3055
Email
schainm@ohsu.edu
Facility Name
Retina Consultants, LLC
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott M McClintic, MD
Phone
503-371-4350
Email
dvetter@salemretina.com
Facility Name
Cascade Medical Research Institute, LLC
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan A. Hunter, MD
Phone
541-687-1927
Email
aprice@cascademedicalresearch.com
Facility Name
Retina-Vitreous Consultants, Inc.
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl R. Olsen, MD
Phone
412-683-5300
Email
merlottil@retinapittsburgh.com
Facility Name
Pittsburg Clinical Trial Consortium
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leanne T. Labriola, DO, MBA
Phone
412-301-5326
Email
michele@pghtrials.com
Facility Name
Southeastern Retina Associates, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph M Googe, Jr, MD
Phone
865-588-0811
Email
koliver@seretina.com
Facility Name
Austin Research Center for Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chirag Jhaveri, MD
Phone
737-704-0130
Email
JTURRIETTA@retinaofaustin.com
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert W Wong, MD
Phone
512-451-0103
Email
rwong@austinretina.com
Facility Name
Retina Consultants of Texas, PA
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles C. Wykoff, MD, PhD
Phone
713-524-3434
Email
ilsa.ortega@retinaconsultantstexas.com
Facility Name
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Y. Weng, MD, MBA
Phone
713-798-3493
Email
Becky.Chatham@bcm.edu
Facility Name
Texas Retina Associates
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Shami, MD
Phone
806-792-0066
Email
ysaldivar@texasretina.com
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darrell E. Baskin, MD
Phone
210-615-1311
Email
ladams@retinasanantonio.com
Facility Name
Gunderson Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bracha, MD
Phone
608-775-0238
Email
srmeyers@gundersenhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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