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Diabetic RetinopathyPhase 3NCT03345901

PROMINENT-Eye Ancillary Study (Protocol AD)

A Phase 3 study testing Pemafibrate in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Jaeb Center for Health Research at 71 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US and other developed… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy, Diabetic Macular Edema
What is being tested?
Pemafibrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
71 sitesin 2 countries
Study dates
15 Jan 2018to 3 Apr 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Already randomized at US or Canadian sites in the PROMINENT study
  • Ability to cooperate with dilated ophthalmic examination and imaging procedures
  • At least one eye meets the following study eye inclusion criteria:
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity level between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central Reading Center grading.

Who cannot join

  • Study eye exclusion criteria are:
  • Neovascularization present. b. Current central-involved diabetic macular edema (DME based on optical coherence tomography (OCT) central subfield thickness (CST) i. Zeiss Cirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µm in women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that in the opinion of the investigator would substantially and adversely affect visual acuity or lead to ocular neovascularization during the course of the study d. Anticipated need for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreous corticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months following randomization e. History of intravitreous anti-VEGF or corticosteroid treatment within the prior year for any indication.
  • History of intraocular surgery within prior 4 months or anticipated within the next 6 months following randomization g. Any history of PRP or vitrectomy h. History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screening i. Aphakia j. Known substantial media opacities that would preclude successful imaging

Trial locations and contacts

71 sites in 2 countries.

71 sites in 2 countries

United States69 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109-5857

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan, 48105

  • Western Carolina Clinical Research, LLC

    Asheville, North Carolina, 28803

  • Emory Eye Center

    Atlanta, Georgia, 30322-1013

  • Emory Eye Center

    Atlanta, Georgia, 30322

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Retina Research Center

    Austin, Texas, 78705

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts, 01432

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237

  • Wilmer Eye Institute at Johns Hopkins

    Baltimore, Maryland, 21287

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Kittner Eye Center

    Chapel Hill, North Carolina, 27517-8923

  • Kittner Eye Center

    Chapel Hill, North Carolina, 27517

  • Charlotte Eye, Ear, Nose and Throat Assoc., PA

    Charlotte, North Carolina, 28210

  • Southeastern Retina Associates

    Chattanooga, Tennessee, 37421

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611-2987

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • Robert E. Torti, MD, PA dba Retina Specialists

    DeSoto, Texas, 75115-2011

  • Valley Retina Institute

    DeSoto, Texas, 75115

  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

    Detroit, Michigan, 48202-2689

  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

    Detroit, Michigan, 48202

  • Retina Vitreous Center

    Edmond, Oklahoma, 73103

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Macula & Retina Institute

    Glendale, California, 91203

  • NorthShore University HealthSystem

    Glenview, Illinois, 60026

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Retina Center of Texas

    Grapevine, Texas, 76051

  • Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030-4101

  • Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Atlantis Eye Care

    Huntington Beach, California, 92647

  • University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent

    Jacksonville, Florida, 32209

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37909

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky, 40509

  • Loma Linda University Health Care, Department of Ophthalmology

    Loma Linda, California, 92354

  • South Coast Retina Center

    Long Beach, California, 90807

  • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service

    Madison, Wisconsin, 53705

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Retina Macula Specialists of Miami

    Miami, Florida, 33126

  • Retina Center, PA

    Minneapolis, Minnesota, 34239

  • Retina Center, PA

    Minneapolis, Minnesota, 55404

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • MaculaCare

    New York, New York, 10021

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois, 60304

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas, 66211

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85021

  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Retina Associates, P.A.

    Shawnee Mission, Kansas, 66204

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York, 13224

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291-4452

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291

  • Retinal Consultants of Southern California Medical Group, Inc.

    Westlake Village, California, 91361

Other trials in United States

Canada2 sites

  • University Health Network - Toronto Western Hospital

    Toronto, M5T 2S8

  • UBC/VCHA Eye Care Centre

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

About this study

Official title: PROMINENT-Eye Ancillary Study: Diabetic Retinopathy Outcomes in a Randomized Trial of Pemafibrate Versus Placebo (Protocol AD)

Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US and other developed countries worldwide. Thus, even a modest ability to prevent DR onset or to slow DR worsening might substantially reduce the number of patients at risk for diabetes-related vision loss worldwide. Widespread use of an oral agent effective at reducing worsening of DR might also decrease the numbers of patients who undergo treatment for DR and diabetic macular edema (DME) and who are consequently at risk for side effects that adversely affect visual function. Two major studies of fenofibrate, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD)-eye study, have demonstrated clinically important reduction in progression of retinopathy in patients with diabetes assigned to fibrate compared with placebo. However, despite the positive clinical trial results, fenofibrate has not gained wide acceptance as a preventive agent by either ophthalmologists or primary diabetes care providers. Thus, it is important to provide further evidence demonstrating whether or not selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity reduces progression of retinopathy in patients with diabetes and non-proliferative diabetic retinopathy at baseline. Pemafibrate is a more potent and selective PPARα modulator than fenofibrate. Its efficacy is currently being evaluated in the Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study for prevention of cardiovascular events in patients with type 2 diabetes. Given the large study cohort with a substantial proportion likely to have DR and the multi-year duration of the PROMINENT trial, this study represents a unique opportunity to assess effects of chronic PPARα activation through pemafibrate therapy on DR outcomes.

Primary Study Objective: To assess whether treatment with pemafibrate (0.2 mg orally BID) compared with placebo reduces the hazard rate of diabetic retinopathy worsening in adults with type 2 diabetes and diabetic retinopathy without neovascularization in at least one eye who are participating in the parent PROMINENT trial.

Being tested
Pemafibrate, Placebo
Keywords
pemafibrate
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemafibrateDrug

    0.2 mg orally BID - twice daily

  • PlaceboDrug

    orally BID - twice daily

Study groups in NCT03345901
Study groupRoleWhat they receive
PemafibrateExperimental.2 mg pemafibrate orally BID
Receives: Drug: Pemafibrate
PlaceboPlacebo comparatorPlacebo pill orally BID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start15 Jan 2018
  3. Primary completion3 Apr 2019
  4. Study completion3 Apr 2019

Why it stopped: recruitment for the substudy did not meet the goals

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03345901
Sponsor's protocol ID
DRCR.net Protocol AD
Status last verified
Aug 2020
First submitted
7 Nov 2017
Last updated
16 Sep 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data related to the eye ancillary study will be made available after completion of the study and publication of the outcome manuscript.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemafibrate in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Jaeb Center for Health Research at 71 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03345901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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