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Proliferative Diabetic RetinopathyPhase 2/3ABNCT02858076

Anti-VEGF vs. Prompt Vitrectomy for VH From PDR

A Phase 2/3 study testing 2-mg Intravitreous Aflibercept Injection and Prompt Vitrectomy Plus Panretinal Photocoagulation in people with Proliferative Diabetic Retinopathy and Vitreous Hemorrhage, run by Jaeb Center for Health Research at 62 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 vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
2-mg Intravitreous Aflibercept Injection and Prompt Vitrectomy Plus Panretinal Photocoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
62 sitesin 2 countries
Study dates
Nov 2016to Jan 2020
Phase
Phase 2/3
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 Participants <18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable.
  • 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 4. Able and willing to provide informed consent. 5. Patient is willing and able to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduled within that time frame.
Show all 12Show fewer
  • 6. Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, for which intervention is deemed necessary.
  • Note: Prior panretinal photocoagulation is neither a requirement nor an exclusion.
  • Subhyaloid hemorrhage alone does not make an eye eligible; however, presence of subhyaloid hemorrhage in addition to the criteria above will not preclude participation provided the investigator is comfortable with either treatment regimen.
  • 7. Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 months to see if hemorrhage clears sufficiently with anti-vascular endothelial growth factor without having to proceed to vitrectomy).
  • 8. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and at least light perception.
  • 9. Investigators should use particular caution when considering enrollment of an eye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefits outweigh the potential risks.

Who cannot join

  • A potential participant is not eligible if any of the following exclusion criteria are present:
  • History of chronic renal failure requiring dialysis (including placement of fistula if performed in preparation for 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.
  • A condition that, in the opinion of the investigator, would preclude participant undergoing elective vitrectomy surgery if indicated during the study.
  • 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.
Show all 33Show fewer
  • Note: participants cannot receive another 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).
  • Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
  • If blood pressure is brought below 180/110 by anti-hypertensive treatment, potential participant can become eligible.
  • Systemic anti-vascular endothelial growth factor or pro-vascular endothelial growth factor treatment within 4 months prior to randomization.
  • These drugs cannot be used during the study.
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next two years.
  • Women who are potential participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
  • Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the two years.
  • Evidence of traction detachment involving or threatening the macula.
  • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
  • Evidence of rhegmatogenous retinal detachment.
  • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
  • Evidence of neovascular glaucoma (iris or angle neovascularization is not an exclusion).
  • Known diabetic macular edema (DME), defined as either
  • Optical coherence tomography central subfield thickness (microns):
  • Zeiss Cirrus: ≥290 in women; ≥305 in men
  • Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
  • Diabetic macular edema on clinical exam that the investigator believes currently requires treatment.
  • History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
  • History of intraocular corticosteroid treatment within 4 months prior to current vitreous hemorrhage onset or after onset.
  • History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.
  • History of vitrectomy.
  • History of YAG capsulotomy performed within 2 months prior to randomization.
  • Aphakia.
  • Uncontrolled glaucoma (in investigator's judgment).
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States60 sites

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan, 48105

  • 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

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, 44122

  • Gailey Eye Clinic

    Bloomington, Illinois, 61704

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • 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

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

    Detroit, Michigan, 48202

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Oregon Retina, LLP

    Eugene, Oregon, 97401

  • Macula & Retina Institute

    Glendale, California, 91203

  • Retina Specialists of Michigan

    Grand Rapids, Michigan, 49546

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030

  • Atlantis Eye Care

    Huntington Beach, California, 92647

  • Raj K. Maturi, MD, PC

    Indianapolis, Indiana, 42690

  • 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

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Retina Center, PA

    Minneapolis, Minnesota, 55404

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

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

    New York, New York, 10003

  • MaculaCare

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10021

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

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

    Pinellas Park, Florida, 33782

  • Shashi D Ganti, MD PC

    Porterville, California, 93257

  • Retina Northwest, PC

    Portland, Oregon, 97221

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota, 55905

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • Retina Associates of Sarasota

    Sarasota, Florida, 34233

  • 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

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291

Other trials in United States

Canada2 sites

  • 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-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy

Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.

Read the detailed description

A participant could have only one eye enrolled in the study.

Being tested
2-mg Intravitreous Aflibercept Injection, Prompt Vitrectomy Plus Panretinal Photocoagulation
Keywords
Anti-VEGF, Vitrectomy
Medical subject headings
Vitreous Hemorrhage

What participants receive

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

  • 2-mg Intravitreous Aflibercept InjectionDrug

    Also called Eylea, Vascular endothelial growth factor Trap-Eye

    Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.

  • Prompt Vitrectomy Plus Panretinal PhotocoagulationProcedure or surgery

    Also called PRP

    Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Study groups in NCT02858076
Study groupRoleWhat they receive
Intravitreous 2 mg aflibercept injectionsActive comparatorInitial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.
Receives: Drug: 2-mg Intravitreous Aflibercept Injection
Prompt vitrectomy plus panretinal photocoagulationActive comparatorFor the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.
Receives: Procedure: Prompt Vitrectomy Plus Panretinal Photocoagulation

What is being measured

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

  1. E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)

    The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up.

    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 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 24 weeks

Secondary outcomes (15)

  1. E-ETDRS Visual Acuity Letter Score

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 4 Weeks

  2. E-ETDRS Visual Acuity Letter Score

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 12 Weeks

  3. E-ETDRS Visual Acuity Letter Score

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 24 Weeks

  4. E-ETDRS Visual Acuity Letter Score

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 1-Year from participant randomization

  5. E-ETDRS Visual Acuity Letter Score

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 2 Years

  6. E-ETDRS Visual Acuity Letter Score (Area Under the Curve 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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. 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.

    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 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 2-Years

  7. Snellen Equivalent Range (Visual Acuity Score)

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 4 weeks

  8. Snellen Equivalent Range (Visual Acuity Score)

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 12 weeks

  9. Snellen Equivalent Range (Visual Acuity Score)

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 24 weeks

  10. Snellen Equivalent Range (Visual Acuity Score)

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

    Measured: 1 year

  11. Snellen Equivalent Range (Visual Acuity Score)

    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 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity..

    Measured: 2 years

  12. Recurrent Vitreous Hemorrhage

    Assessed by the investigator and defined as presence of vitreous hemorrhage after a period of absence. Excludes eyes in which vitreous hemorrhage could not be assessed during follow-up.

    Measured: At any time through 2 years

  13. Retinal Neovascularization on Clinical Exam

    Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined.

    Measured: 24 weeks

  14. Retinal Neovascularization on Clinical Exam

    Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined

    Measured: 1 year

  15. Retinal Neovascularization on Clinical Exam

    Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined

    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 posted8 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJan 2020
  4. Study completionJan 2020

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02858076
Sponsor's protocol ID
DRCR.net Protocol AB
Other IDs
EY14231, EY23207, EY18817
Acronym
AB
Status last verified
Feb 2021
First submitted
3 Aug 2016
Last updated
20 Apr 2021
Data monitoring committee
Yes

Publications

  • Beaulieu WT, Maguire MG, Antoszyk AN; DRCR Retina Network. Changes in activity impairment and work productivity after treatment for vitreous hemorrhage due to proliferative diabetic retinopathy: Secondary outcomes from a randomized controlled trial (DRCR Retina Network Protocol AB). PLoS One. 2023 Nov 16;18(11):e0293543. doi: 10.1371/journal.pone.0293543. eCollection 2023.

    PubMed 37972038

  • Glassman AR, Beaulieu WT, Maguire MG, Antoszyk AN, Chow CC, Elman MJ, Jampol LM, Salehi-Had H, Sun JK; DRCR Retina Network. Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jul 1;139(7):725-733. doi: 10.1001/jamaophthalmol.2021.1110.

    PubMed 33956075

  • Antoszyk AN, Glassman AR, Beaulieu WT, Jampol LM, Jhaveri CD, Punjabi OS, Salehi-Had H, Wells JA 3rd, Maguire MG, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2020 Dec 15;324(23):2383-2395. doi: 10.1001/jama.2020.23027.

    PubMed 33320223

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 2-mg Intravitreous Aflibercept Injection and Prompt Vitrectomy Plus Panretinal Photocoagulation in people with Proliferative Diabetic Retinopathy and Vitreous Hemorrhage, run by Jaeb Center for Health Research at 62 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 12 inclusion and 33 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Jan 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?

E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) (time frame: 24 weeks). 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 NCT02858076, which also lists 3 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 20 Apr 2021.

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