Faricimab + PRP vs. Vitrectomy + Endolaser for Diabetic Retinopathy

(AP Trial)

Recruiting at 13 trial locations

Overseen By Cynthia Stockdale

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jaeb Center for Health Research

Must not be taking: Anti-VEGF

Disqualifiers: Renal disease, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

426 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatment strategies for individuals with proliferative diabetic retinopathy (PDR), a serious eye condition caused by diabetes that can lead to vision loss. Participants will receive either a combination of faricimab (a medication) and panretinal photocoagulation (PRP, a type of laser therapy) or undergo vitrectomy (a surgical procedure) with endolaser treatment. The trial aims to determine which approach better preserves vision and has fewer complications over three years. It seeks participants with diabetes who have PDR requiring treatment and good vision of at least 20/100 in the study eye. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have high blood pressure, it must be controlled with medication to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that faricimab is generally safe for people. Over 100 countries have approved it to treat eye conditions like wet age-related macular degeneration and diabetic eye disease, indicating a strong safety record.

Real-world data also supports faricimab's safety. One study found that patients using faricimab for diabetic eye conditions experienced few side effects, suggesting it is safe for most people.

Vitrectomy, a common surgery for serious eye issues, involves removing the gel inside the eye. While generally safe, it can have risks such as bleeding or infection, though these are rare. Discussing these risks with a doctor is important.

Overall, both treatments are considered safe. Faricimab has a well-established safety record, and vitrectomy is a standard procedure with known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Faricimab for diabetic retinopathy because it offers a fresh approach by targeting two key pathways involved in the disease. Unlike standard treatments like anti-VEGF injections that primarily focus on reducing blood vessel growth, Faricimab blocks both VEGF and Ang-2, potentially improving outcomes by also stabilizing blood vessels. The combination of Faricimab with Panretinal Photocoagulation (PRP) may enhance its effectiveness, offering hope for better control of diabetic retinopathy progression. On the other hand, the Vitrectomy + Endolaser approach provides a surgical option that directly addresses severe cases by removing vitreous gel and applying laser to reduce further damage. This dual approach in the trial highlights the excitement around personalized and potentially more effective treatments for diabetic retinopathy.

What evidence suggests that this trial's treatments could be effective for diabetic retinopathy?

This trial will compare two treatment approaches for diabetic retinopathy: Faricimab combined with panretinal photocoagulation (PRP) and Vitrectomy combined with Endolaser. Research has shown that faricimab, when used with PRP, holds promise for treating diabetic retinopathy. Studies have found that faricimab improves vision clarity and reduces fluid in the retina, which is crucial for diabetic eye conditions. In other diabetic eye diseases, over 90% of patients treated with faricimab experienced no retinal swelling after four years.

Vitrectomy with endolaser is a well-established surgery that removes the gel inside the eye to reduce bleeding or scarring from diabetic retinopathy. This procedure improves vision by clearing blood and repairing damaged areas of the retina. The choice between these treatments in this trial will depend on each participant's specific condition and needs, but both have proven effective in managing diabetic eye disease. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with proliferative diabetic retinopathy (PDR) requiring treatment. Participants must have a diabetes diagnosis, either type 1 or type 2, and maintain a visual acuity of at least 20/100. Both eyes may be eligible if they meet the criteria.

Inclusion Criteria

Both of my eyes may be eligible for the study.

My vision, with correction, is better than 20/100.

I have been diagnosed with diabetes (type 1 or type 2).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either combination of faricimab + PRP or vitrectomy + endolaser

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Endolaser
• Faricimab
• Vitrectomy

Trial Overview The study compares two PDR treatments: one group receives faricimab injections plus panretinal photocoagulation (PRP), while the other undergoes vitrectomy surgery plus endolaser therapy. Outcomes like long-term vision, number of procedures, complications, and costs will be tracked over three years.

How Is the Trial Designed?

Group I: Faricimab + PRP Experimental Treatment 2 Interventions

PRP = Panretinal Photocoagulation

Group II: Vitrectomy + Endolaser Active Control 2 Interventions

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. nature.com nature.com/articles/s41433-025-04059-8

Real-world treatment patterns and visual outcomes of ... PT eyes received 4.5 (1.2) injections in months 1–6 and 2.4 (1.3) in months 7–12. IOI and PIE rates were consistent with faricimab phase 3 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12404257/

Two-Year Real-World Outcomes of Faricimab for Diabetic ... Meanwhile, real-world evidence regarding the long-term efficacy and safety of faricimab remains limited. In particular, most studies ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525000429

Real-World Evidence for Faricimab in Neovascular Age ... Faricimab was associated with improved visual acuity, reduced central choroidal/subfield macular thickness, and reduced/resolved retinal fluid and pigment ...

4. journals.lww.com journals.lww.com/retinajournal/fulltext/2025/07000/effects_of_faricimab_loading_phase_on_diabetic.10.aspx

effects of faricimab loading phase on diabetic macular... Faricimab loading phase showed promising results in visual outcomes and structural improvement in resistant diabetic macular edema.

5. roche.com roche.com/media/releases/med-cor-2024-07-17b

Roche's Vabysmo showed extended durability, continued ... More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint; People treated with Vabysmo sustained ...

6. gene.com gene.com/media/press-releases/15076/2025-09-04/new-data-for-genentechs-vabysmo-reinforc

Genentech: Press Releases | Thursday, Sep 4, 2025 Vabysmo was well tolerated, and safety data were consistent with its known safety profile in wet AMD. To date, Vabysmo is approved in more ...

7. roche.com roche.com/media/releases/med-cor-2025-09-05

New data for Roche's Vabysmo reinforce its efficacy, safety ... To date, Vabysmo is approved in more than 100 countries for nAMD and diabetic ... Four-Year Outcomes of Faricimab in nAMD: Safety and Efficacy ...

8. aaojournal.org aaojournal.org/article/S0161-6420(24)00090-3/fulltext

Efficacy and Safety of Faricimab for Macular Edema due to ... Efficacy and safety of Faricimab for macular edema due to retinal vein occlusion. 24-week results from the BALATON and COMINO trials.