Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Completed · Phase 3

Conditions studied: Proliferative Diabetic Retinopathy

In brief

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy. Secondary objectives include: * Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP. * Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP. * Comparing safety outcomes between treatment groups. * Comparing associated treatment and follow-up exam costs between treatment groups.

Key facts

Study ID

NCT01489189

Run by

Jaeb Center for Health Research

People needed

305

Starts

2012-03-01

Expected to finish

2018-02-05

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years -Individuals < 18 years old are not being included because proliferative diabetic retinopathy (PDR) is so rare in this age group that the diagnosis of PDR 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 (ADA) and/or World Health Organization (WHO) criteria (see Procedures Manual for definitions) Able and willing to provide informed consent.
• Meets at least all of the following ocular criteria criteria:
• Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab, in the investigator's judgment.
• Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score > 24 (approximate Snellen equivalent 20/320) on the day of randomization.
• Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).
• Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality

You may not qualify if…

• Significant renal disease, defined as a history of chronic renal failure requiring 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).
• Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• 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.
• Study participants cannot receive another investigational drug while participating in the study.
• Known allergy to any component of the study drug.
• Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
• If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
• Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
• Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
• These drugs should not be used during the study.
• For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
• Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
• Individual is expecting to move out of the area of the clinical center to an area not covered by another Diabetic Retinopathy Clinical Research Network (DRCR.net) certified clinical center during the 3 years of the study.
• Individual has any of the following ocular characteristics:
• History of prior panretinal photocoagulation (prior PRP is defined as ≥ 100 burns outside of the posterior pole)
• Tractional retinal detachment involving the macula.
• - A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigator's judgment, is not a contraindication to intravitreal ranibizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal ranibizumab
• Exam evidence of neovascularization of the angle (neovascularization of the iris alone is not an exclusion if it does not preclude deferring PRP for at least 4 weeks in the investigator's judgment).
• If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema.
• - An eye should not be considered eligible if:
• macular edema is present that is considered to be related to ocular surgery such as cataract extraction or
• clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of any macular edema.
• An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
• - A vitreous or preretinal hemorrhage is not an exclusion if it is out of the visual axis and in the investigator's judgment is not having any affect on visual acuity.

Where it is running

• Retinal Consultants of AZ — Phoenix, Arizona, United States
• Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda, California, United States
• Southern California Desert Retina Consultants, MC — Palm Springs, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• New England Retina Associates — Trumbull, Connecticut, United States
• Retina Consultants of Southwest Florida — Fort Myers, Florida, United States
• Central Florida Retina Institute — Lakeland, Florida, United States
• Ocala Eye Retina Consultants — Ocala, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Associates of Sarasota — Venice, Florida, United States
• Southeast Retina Center, P.C. — Augusta, Georgia, United States
• North Shore University Health System — Glenview, Illinois, United States
• Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Retina and Vitreous Associates of Kentucky — Lexington, Kentucky, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Elman Retina Group, P.A. — Baltimore, Maryland, United States
• Vitreo-Retinal Associates, PC — Worcester, Massachusetts, United States
• Retina Vitrous Center — Grand Blanc, Michigan, United States
• Barnes Retina Institute — St Louis, Missouri, United States
• Eye Surgical Associates — Lincoln, Nebraska, United States
• The New York Eye and Ear Infirmary/Faculty Eye Practice — New York, New York, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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