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Diabetic RetinopathyPhase 3NCT02634333

Anti-VEGF Treatment for Prevention of PDR/DME

A Phase 3 study testing Prompt aflibercept, Deferred laser and Deferred aflibercept in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Jaeb Center for Health Research at 85 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

Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). 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?
Prompt aflibercept, Deferred laser and Deferred aflibercept
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
85 sitesin 2 countries
Study dates
Jan 2016to 11 May 2022
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 and/or World Health Organization criteria
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  • Able and willing to provide informed consent.
  • Meets all of the following ocular criteria in at least one eye:
  • Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score ≥79 (approximate Snellen equivalent 20/25 or better)
  • Severe non-proliferative diabetic retinopathy (NPDR) (based on the 4:2:1 rule) evident on clinical examination and on digital imaging as judged by the investigator. Reading center grading of less than ETDRS level 43 or greater than 53 is an exclusion.
  • Severe NPDR is defined as:
  • All 4 midperipheral quadrants show severe hemorrhages or microaneurysms (at least as great as Standard photograph 2A, approximately 20 dot and blot hemorrhages), or
  • At least 2 fields of definite venous beading in the midperipheral quadrants or at least 1 field at least as severe as Standard photograph 6A, or
  • At least 1 field of moderate intraretinal microvascular abnormalities (IRMA) in the midperipheral quadrants, at least as severe as Standard photograph 8A
  • No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed).
  • No evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization.
  • The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned.
  • No center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds:
  • Zeiss Cirrus: 290 µm in women and 305 µm in men
  • Heidelberg Spectralis: 305 µm in women and 320 µm in men
  • Investigator and potential participant are comfortable withholding treatment for DME until there is at least a 10% increase in OCT central subfield thickness with confirmed visual acuity loss (10 letter loss at a single visit or 5 to 9 at two consecutive visits).
  • Prompt panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor (anti-VEGF) treatment not required AND investigator and potential participant are willing to wait for development of high-risk characteristics (defined in protocol) to treat PDR.
  • Media clarity, pupillary dilation, and study participant cooperation sufficient to obtain adequate fundus photographs, fluorescein angiogram, and OCT.
  • Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality (including segmentation line placement)

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 that involved treatment within 30 days of randomization with any drug that has not received regulatory approval for the indication being studied.
  • Note: study participants cannot participate in another investigational trial that involves treatment with an investigational drug while participating in the study.
  • Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine prep).
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  • Known allergy to fluorescein dye.
  • 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 2 years.
  • 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 Diabetic Retinopathy Clinical Research Network certified clinical center during the next 2 years.
  • Individual has any of the following ocular characteristics in the eye(s) being evaluated:
  • Exam or photographic evidence of vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR.
  • History of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR.
  • History of prior PRP (defined as ≥100 burns outside of the posterior pole).
  • An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.).
  • History of DME or diabetic retinopathy treatment with laser or intraocular injections of medication within the prior 12 months and no more than 4 prior intraocular injections at any time in the past.
  • Enrollment will be limited to a maximum of 25% of the planned sample size with any history of treatment for DME and/or diabetic retinopathy. Once this number of eyes has been enrolled, any history of treatment for DME and/or diabetic retinopathy will be an exclusion criterion.
  • History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • Any history of vitrectomy.
  • History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization.
  • Aphakia.
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
  • Evidence of uncontrolled glaucoma.
  • Intraocular pressure must be <30, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible.

Trial locations and contacts

85 sites in 2 countries.

85 sites in 2 countries

United States81 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Western Carolina Clinical Research, LLC

    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

  • 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

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, 44122

  • Gailey Eye Clinic

    Bloomington, Illinois, 61704

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • 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

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Carolina Retina Center

    Columbia, South Carolina, 29223

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

    DeSoto, Texas, 75115

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

    Detroit, Michigan, 48202

  • Medical Associates Clinic, P.C.

    Dubuque, Iowa, 52002

  • Oregon Retina, LLP

    Eugene, Oregon, 97401

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Retina Center of Texas

    Grapevine, Texas, 76051

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

  • New England Retina Associates

    Hamden, Connecticut, 06518

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Atlantis Eye Care

    Huntington Beach, California, 92647

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana, 46290

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

    Jacksonville, Florida, 32209

  • Florida Retina Institute-Jacksonville

    Jacksonville, Florida, 32216

  • Mid-America Retina Consultants, P.A.

    Kansas City, Missouri, 64111

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37909

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Loma Linda University Health Care, Department of Ophthalmology

    Loma Linda, California, 92354

  • 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

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Retina Center, PA

    Minneapolis, Minnesota, 55404

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

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

    New York, New York, 10003

  • MaculaCare

    New York, New York, 10021

  • Retinal and Ophthalmic Consultants, PC

    Northfield, New Jersey, 08225

  • East Bay Retina Consultants, Inc.

    Oakland, California, 94609

  • Magruder Eye Institute

    Orlando, Florida, 32803

  • Florida Retina Institute

    Orlando, Florida, 32806

  • 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

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

    Pinellas Park, Florida, 33782

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Shashi D Ganti, MD PC

    Porterville, California, 93257

  • Retina Northwest, PC

    Portland, Oregon, 97210

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Virginia Commonwealth University, Dept. of Ophthalmology

    Richmond, Virginia, 23298

  • University of Rochester

    Rochester, New York, 14642

  • U.C. Davis Eye Center

    Sacramento, California, 95817

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Retina Associates, P.A.

    Shawnee Mission, Kansas, 66204

  • Springfield Clinic, LLP

    Springfield, Illinois, 62703

  • 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

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • 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

Canada4 sites

  • Nova Scotia District Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • Toronto Retina Institute (TRI)

    North York, Ontario, M3C 0G9

  • University Health Network - Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • UBC/VCHA Eye Care Centre

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

About this study

Official title: Intravitreous Anti-Vascular Endothelial Growth Factor Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk

Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently would result in favorable visual acuity outcomes.

If this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe non-proliferative diabetic retinopathy) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented.

Read more

The primary objectives of this protocol are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk PDR or CI-DME with vision loss develops.

Secondary objectives include:

  • Comparing other visual acuity outcomes between treatment groups, such as proportion of eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at least 5 letters at the consecutive study visit just before and at the 2- or 4-year visit
  • Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT central subfield thickness and volume from baseline
  • Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of diabetic retinopathy severity level (scale for individual eyes) by central reading center from baseline
  • Comparing associated treatment and follow-up exam costs between treatment groups
  • Comparing safety outcomes between treatment groups
Being tested
Prompt Sham, Prompt aflibercept, Deferred laser, Deferred aflibercept
Keywords
anti-vascular endothelial growth factor, nonproliferative diabetic retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

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

  • Prompt ShamProcedure or surgery

    A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.

  • Prompt afliberceptDrug

    Also called intravitreal anti-vascular endothelial growth factor, Eylea

    Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.

  • Deferred laserProcedure or surgery

    Also called focal/grid photocoagulation, panretinal photocoagulation

    Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met

  • Deferred afliberceptDrug

    Also called intravitreal anti-vascular endothelial growth factor, Eylea

    Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.

Study groups in NCT02634333
Study groupRoleWhat they receive
Observation (Prompt Sham)Sham comparatorSham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.
Receives: Procedure: Prompt Sham; Procedure: Deferred laser; Drug: Deferred aflibercept
Prompt afliberceptExperimentalAflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.
Receives: Drug: Prompt aflibercept; Procedure: Deferred laser; Drug: Deferred aflibercept

What is being measured

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

  1. Development of PDR and/or DME (Whichever Came First)

    CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)

    Measured: 2 years

  2. Change in Visual Acuity From Baseline

    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

    Measured: 2 years

Secondary outcomes (2)

  1. Change in Visual Acuity From Baseline

    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

    Measured: 4 years

  2. Development of PDR and/or DME (Whichever Came First)

    CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)

    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 posted18 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionMay 2020
  4. Study completion11 May 2022

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02634333
Sponsor's protocol ID
DRCR.net Protocol W
Other IDs
EY14231, EY23207, EY18817
Status last verified
May 2023
First submitted
11 Dec 2015
Last updated
18 Jun 2023
Data monitoring committee
Yes

Publications

  • Maturi RK, Glassman AR, Josic K, Baker CW, Gerstenblith AT, Jampol LM, Meleth A, Martin DF, Melia M, Punjabi OS, Rofagha S, Salehi-Had H, Stockdale CR, Sun JK; DRCR Retina Network. Four-Year Visual Outcomes in the Protocol W Randomized Trial of Intravitreous Aflibercept for Prevention of Vision-Threatening Complications of Diabetic Retinopathy. JAMA. 2023 Feb 7;329(5):376-385. doi: 10.1001/jama.2022.25029.

    PubMed 36749332

  • Maturi RK, Glassman AR, Josic K, Antoszyk AN, Blodi BA, Jampol LM, Marcus DM, Martin DF, Melia M, Salehi-Had H, Stockdale CR, Punjabi OS, Sun JK; DRCR Retina Network. Effect of Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jul 1;139(7):701-712. doi: 10.1001/jamaophthalmol.2021.0606.

    PubMed 33784735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prompt aflibercept, Deferred laser and Deferred aflibercept in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Jaeb Center for Health Research at 85 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 24 inclusion and 27 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 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 24 Nov 2021). 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?

Development of PDR and/or DME (Whichever Came First) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02634333, 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 18 Jun 2023.

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