Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJaeb Center for Health Research
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old
Diagnosis of diabetes mellitus (type 1 or type 2)
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)
Disqualifiers
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).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vitrectomy
Procedure/SurgeryThe 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.
Endolaser
DeviceComplete panretinal photocoagulation (PRP) during vitrectomy
Faricimab
DrugTreatment 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)
DeviceComplete 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.
Treatment groups
426 Participants
are divided into 2 treatment groupsGroup A: Faricimab + PRPExperimental treatment 2 interventions
Group B: Vitrectomy + EndolaserActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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- years2
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Initial randomized treatment will be excluded.
Time frame
Over 3 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov