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Diabetic Macular EdemaPhase 3Protocol VNCT01909791

Treatment for CI-DME in Eyes With Very Good VA Study

A Phase 3 study testing Prompt Laser, Prompt aflibercept and Deferred laser in people with Diabetic Macular Edema, run by Jaeb Center for Health Research at 103 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Prompt Laser, Prompt aflibercept and Deferred laser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
702 participants
Where
103 sitesin 2 countries
Study dates
Oct 2013to 11 Sep 2018
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

  • Age >= 18 years
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Any one of the following will be considered to be sufficient evidence that diabetes is present:
  • Current regular use of insulin for the treatment of diabetes
  • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  • Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria.
Show all 15Show fewer
  • Able and willing to provide informed consent.
  • Meets all of the following ocular criteria in at least the one eye:
  • Best corrected E-ETDRS visual acuity letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days.
  • On clinical exam, definite retinal thickening due to DME involving the center of the macula.
  • Diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days.
  • Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality.
  • The investigator is comfortable with the eye being randomized to any of the three treatment groups (observation, laser, or anti-VEGF initially).
  • If focal/grid photocoagulation is contraindicated because all leaking microaneurysms are too close to the fovea or the investigator believes the DME that is present will not benefit from focal/grid photocoagulation, the eye should not be enrolled.
  • Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.

Who cannot join

  • History of chronic renal failure requiring dialysis or kidney transplant.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
  • Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
  • Note: study participants cannot receive another investigational drug while participating in the study.
  • Known allergy to any component of the study drug.
Show all 28Show fewer
  • Blood pressure >180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
  • Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
  • These drugs should not be used during the study.
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.
  • Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
  • Individual is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 24 months of the study.
  • Individual has any of the following ocular characteristics:
  • Macular edema is considered to be due to a cause other than DME.
  • An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema.
  • An ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
  • An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
  • Cataract is present that, in the opinion of the investigator, may alter visual acuity during the course of the study.
  • Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF).
  • History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment within 30 days prior to randomization.
  • History of intravitreal or peribulbar corticosteroid within 4 months prior to randomization for an ocular condition other than DME.
  • Any history of or anticipated need for intravitreal anti-VEGF within the next 6 months for an ocular condition other than DME (e.g. choroidal neovascularization, central retinal vein occlusion, PDR).
  • History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
  • Any history of vitrectomy.
  • History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • History of YAG capsulotomy performed within 2 months prior to randomization.
  • Aphakia.
  • Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.

Trial locations and contacts

103 sites in 2 countries.

103 sites in 2 countries

United States100 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87102

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan, 48105

  • Western Carolina Retinal Associates, PA

    Asheville, North Carolina, 28803

  • Emory Eye Center

    Atlanta, Georgia, 30322

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237

  • Wilmer Eye Institute at Johns Hopkins

    Baltimore, Maryland, 21287-9277

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, 44122

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Ross Eye Institute, SUNY Buffalo

    Buffalo, New York, 14209

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7040

  • 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

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Carolina Retina Center

    Columbia, South Carolina, 29223

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

    Detroit, Michigan, 48202

  • Medical Associates Clinic, P.C.

    Dubuque, Iowa, 52002

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Oregon Retina, LLP

    Eugene, Oregon, 97401

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • NorthShore University HealthSystem

    Glenview, Illinois, 60026

  • Retina Vitreous Center

    Grand Blanc, Michigan, 48439

  • Retina Specialists of Michigan

    Grand Rapids, Michigan, 49525

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Raj Maturi

    Indianapolis, Indiana, 46290

  • University of Florida College of Med., Department of Ophthalmology

    Jacksonville, Florida, 32209

  • Illinois Retina Associates

    Joliet, Illinois, 60435

  • Mid-America Retina Consultants, P.A.

    Kansas City, Missouri, 64111

  • Southeastern Retina Associates, PC

    Kingsport, Tennessee, 37660

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37909

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Family Eye Group

    Lancaster, Pennsylvania, 17601-2644

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky, 40509

  • Jones Eye Institute/University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205-7199

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California, 92354

  • South Coast Retina Center

    Long Beach, California, 90807

  • Texas Retina Associates

    Lubbock, Texas, 79424

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

    Madison, Wisconsin, 53705

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Retina Macula Specialists of Miami

    Miami, Florida, 33126

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Retina Center, PA

    Minneapolis, Minnesota, 55404

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • Retina Group of New England

    New London, Connecticut, 06320

  • The New York Eye and Ear Infirmary/Faculty Eye Practice

    New York, New York, 10003

  • MaculaCare

    New York, New York, 10021

  • The Institute of Ophthalmology and Visual Science (IOVS)

    Newark, New Jersey, 07103

  • Retinal and Ophthalmic Consultants, PC

    Northfield, New Jersey, 08225

  • New England Retina Associates

    Norwich, Connecticut, 06360

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452

  • Ocala Eye Retina Consultants

    Ocala, Florida, 34474

  • Magruder Eye Institute

    Orlando, Florida, 32803

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Southern California Desert Retina Consultants, MC

    Palm Desert, California, 92211

  • University of Pennsylvania Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85021

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retina Northwest, PC

    Portland, Oregon, 97210

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Eyesight Ophthalmic Services, PA

    Portsmouth, New Hampshire, 03801

  • University of Kansas Medical Center, Dept. of Ophthalmology

    Prairie Village, Kansas, 66208

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Virginia Commonwealth University, Dept. of Ophthalmology

    Richmond, Virginia, 23298

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota, 55905

  • Retina Associates of Western New York

    Rochester, New York, 14618

  • University of Rochester

    Rochester, New York, 14642

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95841

  • Andersen Eye Associates

    Saginaw, Michigan, 48603

  • Retina Associates of Utah, P.C.

    Salt Lake City, Utah, 84107

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Center for Sight

    Sarasota, Florida, 34239

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • University of Washington Medical Center

    Seattle, Washington, 98104

  • Retina Associates, P.A.

    Shawnee Mission, Kansas, 66204

  • Spokane Eye Clinic

    Spokane, Washington, 99204

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York, 13224

  • Retina Associates of Florida, P.A.

    Tampa, Florida, 33609

  • University of Arizona Medical Center/Department of Ophthalmology

    Tucson, Arizona, 85711

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Retinal Consultants of Southern California Medical Group, Inc.

    Westlake Village, California, 91361

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

Canada3 sites

  • Alberta Retina Consultants

    Edmonton, Alberta, T5H 0X5

  • University Health Network - Toronto Western Hospital

    Toronto, Ontario, M5T 258

  • UBC/VCHA Eye Care Centre

    Vancouver, V5Z 3N9

Other trials in Canada

About this study

Official title: Treatment for Central-Involved Diabetic Macular Edema in Eyes With Very Good Visual Acuity

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens.

The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF.

Read more

Secondary objectives include:

  • Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity
  • For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment
  • Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness
  • Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups
  • Comparing safety outcomes between treatment groups
  • Comparing associated treatment and follow-up exam costs between treatment groups
Being tested
Prompt Laser, Prompt aflibercept, Deferred laser, Deferred aflibercept
Keywords
Diabetic Macular Edema, anti-vascular endothelial growth factor

What participants receive

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

  • Prompt LaserProcedure or surgery

    Also called focal/grid photocoagulation, laser treatment

    Focal/grid laser performed at baseline and as needed during follow-up

  • Prompt afliberceptDrug

    Also called intravitreal anti-VEGF, Eylea

    Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria

  • Deferred laserProcedure or surgery

    Also called focal/grid photocoagulation, laser treatment

    Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met

  • Deferred afliberceptDrug

    Also called intravitreal anti-VEGF, Eylea

    Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Study groups in NCT01909791
Study groupRoleWhat they receive
Prompt Laser + Deferred AfliberceptExperimentalFocal/grid laser followed by intravitreal aflibercept if vision worsens
Receives: Procedure: Prompt Laser; Drug: Deferred aflibercept
Observation + Deferred AfliberceptActive comparatorNo treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Receives: Procedure: Deferred laser; Drug: Deferred aflibercept
Prompt AfliberceptExperimentalIntravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Receives: Drug: Prompt aflibercept; Procedure: Deferred laser

What is being measured

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

  1. Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline

    Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).

    Measured: 2 years

Secondary outcomes (17)

  1. Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline

    Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).

    Measured: 1 year

  2. Change in E-ETDRS Visual Acuity Letter Score From Baseline

    Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).

    Measured: 1 year

  3. Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve)

    Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up.

    Measured: 2 year

  4. Change in OCT Central Subfield Thickness From Baseline

    Measured: 2 years

  5. Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening

    Logarithmic transformation of optical coherence tomography central subfield thickness (CST) is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.

    Measured: 1 year

  6. Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease

    Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.

    Measured: 1 year

  7. Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant

    Measured: 1 year

  8. Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy

    Includes eyes with baseline severity level of 75 (high-risk proliferative diabetic retinopathy) or less based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale.

    Measured: 2 years

  9. For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment

    Measured: 2 years

  10. Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline

    Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).

    Measured: 2 years

  11. Change in E-ETDRS Visual Acuity Letter Score From Baseline

    Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).

    Measured: 2 years

  12. Change in OCT Central Subfield Thickness From Baseline

    Measured using spectral-domain optical coherence tomography (OCT).

    Measured: 1 year

  13. Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening

    Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.

    Measured: 2 years

  14. Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease

    Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.

    Measured: 2 years

  15. Cumulative Number of Focal/Grid Photocoagulation Sessions Performed Per Participant

    Measured: 2 years

  16. Number of Eyes With ≥ 2-step Improvement of Diabetic Retinopathy

    Includes eyes with baseline severity level of 35 (mild non-proliferative diabetic retinopathy) or greater based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale. Excludes eyes with severity level 60 at baseline since improvement is not possible in these eyes.

    Measured: 2 years

  17. Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant

    Measured: 2 years

Timeline

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

  1. First posted29 Jul 2013 (estimated)
  2. Study startOct 2013
  3. Primary completion11 Sep 2018
  4. Study completion11 Sep 2018

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01909791
Sponsor's protocol ID
DRCR.net Protocol V
Other IDs
EY14231, EY23207, EY18817
Acronym
Protocol V
Status last verified
Jul 2020
First submitted
23 Jul 2013
Last updated
31 Jul 2020
Data monitoring committee
Yes

Publications

  • Glassman AR, Baker CW, Beaulieu WT, Bressler NM, Punjabi OS, Stockdale CR, Wykoff CC, Jampol LM, Sun JK; DRCR Retina Network. Assessment of the DRCR Retina Network Approach to Management With Initial Observation for Eyes With Center-Involved Diabetic Macular Edema and Good Visual Acuity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2020 Apr 1;138(4):341-349. doi: 10.1001/jamaophthalmol.2019.6035.

    PubMed 32077907

  • Baker CW, Glassman AR, Beaulieu WT, Antoszyk AN, Browning DJ, Chalam KV, Grover S, Jampol LM, Jhaveri CD, Melia M, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial. JAMA. 2019 May 21;321(19):1880-1894. doi: 10.1001/jama.2019.5790.

    PubMed 31037289

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prompt Laser, Prompt aflibercept and Deferred laser in people with Diabetic Macular Edema, run by Jaeb Center for Health Research at 103 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 15 inclusion and 28 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: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 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. 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 3 Jan 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?

Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline (time frame: 2 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 NCT01909791, which also lists 2 linked publications.

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 31 Jul 2020.

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