Proliferative Diabetic Retinopathy (PDR)Phase 3APNCT06790784
Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
A Phase 3 study testing Vitrectomy, Endolaser and Faricimab in people with Proliferative Diabetic Retinopathy (PDR), run by Jaeb Center for Health Research at 34 sites in United States.
Trial summary
This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy (PDR)
- What is being tested?
- Vitrectomy, Endolaser and Faricimab
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 34 sitesUnited States
- Study dates
- 4 Aug 2025to Aug 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Individual:
- ≥ 18 years old
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)
- Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center
- Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)
Who cannot join
- Individual:
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Blood pressure > 160/100 (systolic above 160 or diastolic above 100).
- o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up.
Show all 14Show fewer
- Study Eye: (A participant can have two study eyes.)
- Traction retinal detachment involving the macula
- Significant vitreous hemorrhage that would preclude completion of a full PRP
- Significant vitreomacular traction
- Any prior vitrectomy
- Any prior PRP (defined as ≥100 burns outside of the posterior pole)
- Treatment for DME within the prior 6 months
- Intravitreal anti-VEGF for any indication, other than DME, within the prior year
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
United States34 sites, 34 recruiting
- Recruiting
Emory Eye Center
Atlanta, Georgia, 30322
Andrew M Hendrick, MD, 404-778-4261, mafif@emory.edu
- Recruiting
Southeast Retina Center, P.C.
Augusta, Georgia, 30909
Dennis M. Marcus, MD, (706) 650-0061, amitchell@southeastretina.com
- Recruiting
Austin Research Center for Retina
Austin, Texas, 78705
Chirag Jhaveri, MD, 737-704-0130, beatris.ramirez@nvisioncenters.com
- Recruiting
Elman Retina Group, P.A.
Baltimore, Maryland, 21237
Michael J. Elman, MD, 410-686-3000, Starr@elmanretina.com
- Recruiting
Retina Consultants of Texas, PA
Bellaire, Texas, 77401
Hasenin Al-Khersan, MD, 713-524-3434, rebecca.clark@retinaconsultantstexas.com
- Recruiting
Boston Medical Center Corporation
Boston, Massachusetts, 02118
Nicole H. Siegel, MD, 617-414-4020, sreevardhan.alluri@bmc.org
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Jennifer K Sun, MD, MPH, 617-309-2520, cashrafz@joslin.harvard.edu
- Recruiting
Midwest Eye Institute
Carmel, Indiana, 46032
Raj K. Maturi, MD, 317-817-1414, haydenb@midwesteye.com
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517-8923
Jan N. Ulrich, MD, 919-966-5296, wrena@email.unc.edu
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Sara Fard, 312-942-2117, luma_halig@rush.edu
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Yu-Guang He, MD, 214-645-2012, norma.ortegon@utsouthwestern.edu
- Recruiting
Retina Vitreous Center
Edmond, Oklahoma, 73013
Sandeep N. Shah, (405) 607-6699, bell@rvcoklahoma.com
- Recruiting
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, 77030-4101
Christina Y Weng, MD, MBA, 713-798-3493, Peter.Rico@bcm.edu
- Recruiting
Retina Associates of Southern California
Huntington Beach, California, 92647
Hani Salehi-Had, MD, 657-227-9496, v.phan@retinasocal.com
- Recruiting
The Trustees of Indiana University
Indianapolis, Indiana, 46202
Amir R. Hajrasouliha, MD, 317-944-2020, skarra@iu.edu
- Recruiting
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Sandeep Grover, MD, 904-244-9361, ghulam.hamdani@jax.ufl.edu
- Recruiting
Florida Retina Consultants
Lakeland, Florida, 33805
Scott M. Friedman, MD, 863-682-7474, Dfagan@frc2020.com
- Recruiting
University of Kentucky Advanced Eye Care
Lexington, Kentucky, 40508
Leanne M. Clevenger, MD, 8595623570, evelyn.Gonzalez@uky.edu
- Recruiting
Loma Linda University
Loma Linda, California, 92354
David I. Sierpina, MD, 909-558-2169, nborntrager@llu.edu
- Recruiting
Texas Retina Associates
Lubbock, Texas, 79424
Michel Shami, MD, 806-792-0066, afuller@texasretina.com
- Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146
Shripaad Shukla, MD, 412-683-5300, merlottil@retinapittsburgh.com
- Recruiting
Illinois Retina Associates SC Oak Park Site
Oak Park, Illinois, 60304
Naryan S. Sabherwal, MD, 708-660-8450, vruiz@illinoisretina.com
- Recruiting
Ophthalmic Partners of Florida, PA dba Central Florida Retina
Orlando, Florida, 32806
Gokul Kumar, MD, 407-425-7188, vbell@cfretina.com
- Recruiting
Mid-America Retina Consultants, P.A.
Overland, Kansas, 66211
William N. Rosenthal, MD, (913) 663-5900, sjohnson@midamericaretina.com
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Andrew J. Barkmeier, MD, 507-538-8119, Taylor.Laura2@mayo.edu
- Recruiting
Retina Associates of Western NY, P.C.
Rochester, New York, 14620
Edward F. Hall, MD, 585-442-3411, mdoran@retinaassociatesofwny.com
- Recruiting
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416
Abdhish R. Bhavsar, MD, 612-871-2292, agilchrist@RetinaMN.com
- Recruiting
West Coast Retina Medical Group, Inc.
San Francisco, California, 94109
Georgia N. Kamboj, MD, 415-972-4600, ashapiro@westcoastretina.com
- Recruiting
Thomas Eye Group
Sandy Springs, Georgia, 30328
Paul L Kaufman, MD, 404-256-1507, kathyw@thomaseye.com
- Recruiting
California Retina Consultants
Santa Barbara, California, 93103-4223
Dante J. Pieramici, MD, 805-963-1648, Nancyc@californiaretina.com
- Recruiting
Retina Research Institute, LLC
St Louis, Missouri, 63128
Kevin J. Blinder, MD, 314-367-1181, rhonda.weeks@rc-stl.com
- Recruiting
Retina Associates of Florida, LLC
Tampa, Florida, 33609
Ivan J. Suner, MD, 813-875-6373, retinaklongworth@gmail.com
- Recruiting
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, 50266
David J. Massop, 515-223-8685, twoehl@wolfeclinic.com
- Recruiting
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, 71291-4452
Ruben A. Grigorian, 318-325-2610, lbmoore@eyenela.com
About this study
Official title: A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy
This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.
Read the detailed description
Although some combination of anti-VEGF plus PRP is the most common treatment approach for PDR with and without DME, there are currently no long-term data on a standardized approach. Vitrectomy is not currently used as first-line treatment for early PDR but advances in surgical technique have reduced associated complications and the ability to remove the posterior hyaloid during surgery may have advantages over nonsurgical approaches, especially in the reduction of vitreous hemorrhage and/or traction retinal detachment that may occur later when the hyaloid separates naturally. Protocol S demonstrated both PRP and anti-VEGF alone result in good visual acuity results long-term so it is expected that a combination treatment would also result in good visual acuity results.
This study will evaluate the safety and efficacy of two treatment strategies for PDR: faricimab plus PRP and Vitrectomy with endolaser with the goal to determine whether either approach decreases visit and treatment burden along with decreasing complications compared with the other treatment method while maintaining good visual acuity. The primary objectives of this study are to compare visual acuity at 3 years following vitrectomy with endolaser or faricimab+PRP and to compare number of treatments for PDR (i.e., injections, PRP, vitrectomy) following the end of randomized treatment over 3 years.
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Being tested
- Vitrectomy, Endolaser, Faricimab, Panretinal Photocoagulation (PRP)
- Keywords
- faricimab, vitrectomy, endolaser, panretinal photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
The vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted.
EndolaserDevice
Complete panretinal photocoagulation (PRP) during vitrectomy
FaricimabDrug
Treatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization.
Panretinal Photocoagulation (PRP)Device
Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization.
| Study group | Role | What they receive |
|---|---|---|
| Faricimab + PRP | Experimental | PRP = Panretinal Photocoagulation Receives: Drug: Faricimab; Device: Panretinal Photocoagulation (PRP) |
| Vitrectomy + Endolaser | Active comparator | Not described Receives: Procedure: Vitrectomy; Device: Endolaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Change 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.
Measured: Baseline to 3- years
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Initial randomized treatment will be excluded.
Measured: Over 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start4 Aug 2025
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic Retinopathy (PDR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790784
- Sponsor's protocol ID
- Protocol AP
- Other IDs
- UG1EY014231
- Acronym
- AP
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06790784
- Acronym / sponsor ID
- AP / Protocol AP
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Keywords
- faricimab, vitrectomy, endolaser, panretinal photocoagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Genentech, Inc.
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.
Detailed description
Although some combination of anti-VEGF plus PRP is the most common treatment approach for PDR with and without DME, there are currently no long-term data on a standardized approach. Vitrectomy is not currently used as first-line treatment for early PDR but advances in surgical technique have reduced associated complications and the ability to remove the posterior hyaloid during surgery may have advantages over nonsurgical approaches, especially in the reduction of vitreous hemorrhage and/or traction retinal detachment that may occur later when the hyaloid separates naturally. Protocol S demonstrated both PRP and anti-VEGF alone result in good visual acuity results long-term so it is expected that a combination treatment would also result in good visual acuity results.
This study will evaluate the safety and efficacy of two treatment strategies for PDR: faricimab plus PRP and Vitrectomy with endolaser with the goal to determine whether either approach decreases visit and treatment burden along with decreasing complications compared with the other treatment method while maintaining good visual acuity. The primary objectives of this study are to compare visual acuity at 3 years following vitrectomy with endolaser or faricimab+PRP and to compare number of treatments for PDR (i.e., injections, PRP, vitrectomy) following the end of randomized treatment over 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faricimab + PRP | Experimental | Drug: Faricimab, Device: Panretinal Photocoagulation (PRP)PRP = Panretinal Photocoagulation |
| Vitrectomy + Endolaser | Active comparator | Procedure: Vitrectomy, Device: Endolaser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years old
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)
- Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center
- Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)
Key exclusion criteria (14 listed)
- Individual:
- o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible.
- Study Eye: (A participant can have two study eyes.)
- Traction retinal detachment involving the macula
- Significant vitreous hemorrhage that would preclude completion of a full PRP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitrectomyThe vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted. | Procedure or surgery | Vitrectomy + Endolaser |
| EndolaserComplete panretinal photocoagulation (PRP) during vitrectomy | Device | Vitrectomy + Endolaser |
| FaricimabTreatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization. | Drug | Faricimab + PRP |
| Panretinal Photocoagulation (PRP)Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization. | Device | Faricimab + PRP |
Primary outcome
Visual Acuity Change from Baseline
Time frame: Baseline to 3- years
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.
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Time frame: Over 3 Years
Initial randomized treatment will be excluded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitrectomy, Endolaser and Faricimab in people with Proliferative Diabetic Retinopathy (PDR), run by Jaeb Center for Health Research at 34 sites in United States.
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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Stockdale (8139758690, drcrnet@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity Change from Baseline (time frame: Baseline to 3- 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?
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 Sep 2026.