A Phase 3 interventional study of Vitrectomy and Endolaser in Proliferative Diabetic Retinopathy (PDR), sponsored by Jaeb Center for Health Research. Recruiting at 34 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment
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Among 11 studies in Diabetic Retinopathy by Jaeb Center for Health Research — 1 open to participants now, 2 under way, 2 of them phase 3. Diabetic Retinopathy · Jaeb Center for Health Research.
Among the 11 studies in Diabetic Retinopathy by Jaeb Center for Health Research, this one is the only one that started in 2025, is one of 8 in phase 3, and was the 11th registered.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
Browse Diabetic Retinopathy studies →1 of the 11 studies in Diabetic Retinopathy by Jaeb Center for Health Research is open now, in 1 country.
By country, each count listing its studies:
Of the 92 Diabetic Retinopathy studies recruiting now, 60 (65%) set no upper age limit and 10 (11%) stop at 75 or younger; 8 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 426 is above the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.
Median enrollment 399 across the 9 interventional studies, 105 across the 2 observational. Of the 9 that completed or were terminated, 7 (78%) have results posted.
This tab as a report to print or save as PDF → With an account.
Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Diabetic Retinopathy by Jaeb Center for Health Research, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individual:
Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)
Exclusion Criteria:
Individual:
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 : pregnant or lactating or intending to become pregnant within the next 3 years.
Study Eye: (A participant can have two study eyes.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRP = Panretinal Photocoagulation
Drug: Faricimab · Device: Panretinal Photocoagulation (PRP)
Procedure: Vitrectomy · Device: Endolaser
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.
Complete panretinal photocoagulation (PRP) during vitrectomy
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.
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.
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.
Time frame: Baseline to 3- years
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Initial randomized treatment will be excluded.
Time frame: Over 3 Years
Started Aug 2025 (actual). Primary completion is estimated for Aug 2031, 72 months after the start.
Of 21 phase 3 interventional studies under Diabetic Retinopathy, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 41. This study's planned 72 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Faricimab
Jaeb Center for Health Research →