Factors Associated with Worsening Proliferative Diabetic Retinopathy in Eyes Treated with Panretinal Photocoagulation or Ranibizumab.
To compare rates and identify predictive factors for events that represent worsening of proliferative diabetic retinopathy (PDR) in eyes treated with panretinal photocoagulation (PRP) or ranibizumab.



Randomized clinical trial (55 United States sites).



Three hundred ninety-four study eyes from 305 adults with PDR, visual acuity (VA) 20/320 or better, and no history of PRP.



Panretinal photocoagulation or intravitreous ranibizumab injections (0.5 mg/0.05 ml).



Time from randomization to a composite PDR-worsening outcome defined as the first occurrence of vitreous hemorrhage, retinal detachment, anterior segment neovascularization, or neovascular glaucoma.



Through 2 years, the cumulative probability of worsening PDR was 42% (PRP) versus 34% (ranibizumab; hazard ratio [HR], 1.33; 99% confidence interval [CI], 0.90 to 1.98; P = 0.063). Worse baseline levels of diabetic retinopathy severity (Early Treatment Diabetic Retinopathy Study scale) were associated with increased risk of worsening PDR, regardless of treatment group (64% [high-risk PDR or worse] vs. 23% [moderate PDR or better]; HR, 3.97; 99% CI, 2.48 to 6.36; P < 0.001). In the PRP group, eyes receiving pattern scan versus conventional single-spot PRP also were at higher risk for worsening PDR (60% vs. 39%; HR, 2.04; 99% CI, 1.02 to 4.08; P = 0.008), regardless of the number of spots placed or the number of sittings to complete the initial PRP. Eyes in both groups with vision-impairing (VA 20/32 or worse) center-involved diabetic macular edema (DME) at baseline were required to receive ranibizumab for center-involved DME. Therefore the composite outcome was compared by treatment in the subgroup of eyes that did not have vision-impairing center-involved DME at baseline. For these eyes, the rate of PDR-worsening was greater with PRP than ranibizumab (45% vs. 31%; HR, 1.62; 99% CI, 1.01 to 2.60; P = 0.008).



In eyes with PDR, ranibizumab resulted in less PDR worsening compared with PRP, especially in eyes not required to receive ranibizumab for center-involved DME. Although anti-vascular endothelial growth factor therapy requires a more frequent visit schedule than PRP, these findings provide additional evidence supporting the use of ranibizumab as an alternative therapy to PRP for PDR, at least through 2 years.
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Susan B
SB
Bressler
Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat8@jaeb.org.
Wesley T
WT
Beaulieu
Jaeb Center for Health Research, Tampa, Florida.
Adam R
AR
Glassman
Carolina Retina Center PA, Columbia, South Carolina.
Jeffrey G
JG
Gross
Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Lee M
LM
Jampol
Jaeb Center for Health Research, Tampa, Florida.
Michele
M
Melia
Retina Northwest, Portland, Oregon.
Mark A
MA
Peters
Loma Linda University Health Care, Loma Linda, California.
Michael E
ME
Rauser
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000869:Anterior Eye Segment / Q000098:blood supply; D003930:Diabetic Retinopathy / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D018450:Disease Progression; D005260:Female; D015355:Glaucoma, Neovascular / Q000175:diagnosis; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation; D008297:Male; D008875:Middle Aged; D009389:Neovascularization, Pathologic / Q000175:diagnosis; D016016:Proportional Hazards Models; D000069579:Ranibizumab / Q000627:therapeutic use*; D012163:Retinal Detachment / Q000175:diagnosis; D012307:Risk Factors; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology; D014823:Vitreous Hemorrhage / Q000175:diagnosis; D055815:Young Adult
D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab