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Original Investigation | Clinical Sciences

Exploratory Analysis of the Effect of Intravitreal Ranibizumab or Triamcinolone on Worsening of Diabetic Retinopathy in a Randomized Clinical Trial

Susan B. Bressler, MD1; Haijing Qin, MS2; Michele Melia, ScM2; Neil M. Bressler, MD1; Roy W. Beck, MD, PhD2; Clement K. Chan, MD3; Sandeep Grover, MD4; David G. Miller, MD5 ; for the Diabetic Retinopathy Clinical Research Network
[+] Author Affiliations
1Retina Division, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland
2Jaeb Center for Health Research, Tampa, Florida
3Southern California Desert Retina Consultants, Palm Springs
4Department of Ophthalmology, Jacksonville Health Science Center, University of Florida College of Medicine, Gainesville
5Retina Associates of Cleveland Inc, Cleveland, Ohio
JAMA Ophthalmol. 2013;131(8):1033-1040. doi:10.1001/jamaophthalmol.2013.4154.
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Published online

Importance  The standard care for proliferative diabetic retinopathy (PDR) usually is panretinal photocoagulation, an inherently destructive treatment that can cause iatrogenic vision loss. Therefore, evaluating the effects of therapies for diabetic macular edema on development or worsening of PDR might lead to new therapies for PDR.

Objective  To evaluate the effects of intravitreal ranibizumab or triamcinolone acetonide, administered to treat diabetic macular edema, on worsening of diabetic retinopathy.

Design  Exploratory analysis was performed on worsening of retinopathy, defined as 1 or more of the following: (1) worsening from no PDR to PDR, (2) worsening of 2 or more severity levels on reading center assessment of fundus photographs in eyes without PDR at baseline, (3) having panretinal photocoagulation, (4) experiencing vitreous hemorrhage, or (5) undergoing vitrectomy for the treatment of PDR.

Setting  Community- and university-based ophthalmology practices.

Participants  Individuals with central-involved diabetic macular edema causing visual acuity impairment.

Interventions  Eyes were assigned randomly to sham with prompt focal/grid laser, 0.5 mg of intravitreal ranibizumab with prompt or deferred (≥24 weeks) laser, or 4 mg of intravitreal triamcinolone acetonide with prompt laser.

Main Outcomes and Measures  Three-year cumulative probabilities for retinopathy worsening.

Results  For eyes without PDR at baseline, the 3-year cumulative probabilities for retinopathy worsening (P value comparison with sham with prompt laser) were 23% using sham with prompt laser, 18% with ranibizumab with prompt laser (P = .25), 7% with ranibizumab with deferred laser (P = .001), and 37% with triamcinolone with prompt laser (P = .10). For eyes with PDR at baseline, the 3-year cumulative probabilities for retinopathy worsening were 40%, 21% (P = .05), 18% (P = .02), and 12% (P < .001), respectively.

Conclusions and Relevance  Intravitreal ranibizumab appears to be associated with a reduced risk of diabetic retinopathy worsening in eyes with or without PDR. Intravitreal triamcinolone also appears to be associated with a reduced risk of PDR worsening. These findings suggest that use of these drugs to prevent worsening of diabetic retinopathy may be feasible. Given the exploratory nature of these analyses, the risk of endophthalmitis following intravitreal injections, and the fact that intravitreal triamcinolone can cause cataract or glaucoma, use of these treatments to reduce the rates of worsening of retinopathy, with or without PDR, does not seem warranted at this time.

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Figure 1.
Cumulative Probability of Worsening of Retinopathy Among Eyes Without Proliferative Diabetic Retinopathy

P values for comparison with sham with prompt laser for ranibizumab with prompt laser, ranibizumab with deferred laser (Def), and triamcinolone acetonide with prompt laser were .04, .04, and .04 at 1 year; .01, .005, and .64 at 2 years, and .25, .001, and .10 at 3 years, respectively. Each visit week included visits that were ±14 days except the 52-, 68-, 84-, 120-, and 136-week visits, which were ±8 weeks, and the 104- and 156-week visits, which were ±16 weeks.

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Place holder to copy figure label and caption
Figure 2.
Cumulative Probability of Worsening of Retinopathy Among Eyes With Proliferative Diabetic Retinopathy

P value for comparison with sham with prompt laser for ranibizumab with prompt laser, ranibizumab with deferred laser (Def), and triamcinolone acetonide with prompt laser throughout the 3 years of follow-up were .05, .02, and <.001, respectively. Each visit week included visits that were ±14 days except the 52-, 68-, 84-, 120-, and 136-week visits, which were ±8 weeks, and the 104- and 156-week visits, which were ±16 weeks.

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