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Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.

Publication ,  Journal Article
Gross, JG; Glassman, AR; Liu, D; Sun, JK; Antoszyk, AN; Baker, CW; Bressler, NM; Elman, MJ; Ferris, FL; Gardner, TW; Jampol, LM; Martin, DF ...
Published in: JAMA Ophthalmol
October 1, 2018

IMPORTANCE: Ranibizumab is a viable treatment option for eyes with proliferative diabetic retinopathy (PDR) through 2 years. However, longer-term results are needed. OBJECTIVE: To evaluate efficacy and safety of 0.5-mg intravitreous ranibizumab vs panretinal photocoagulation (PRP) over 5 years for PDR. DESIGN, SETTING, AND PARTICIPANTS: Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial evaluated 394 study eyes with PDR enrolled February through December 2012. Analysis began in January 2018. INTERVENTIONS: Eyes were randomly assigned to receive intravitreous ranibizumab (n = 191) or PRP (n = 203). Frequency of ranibizumab was based on a protocol-specified retreatment algorithm. Diabetic macular edema could be managed with ranibizumab in either group. MAIN OUTCOMES AND MEASURES: Mean change in visual acuity (intention-to-treat analysis) was the main outcome. Secondary outcomes included peripheral visual field loss, development of vision-impairing diabetic macular edema, and ocular and systemic safety. RESULTS: The 5-year visit was completed by 184 of 277 participants (66% excluding deaths). Of 305 enrolled participants, the mean (SD) age was 52 (12) years, 135 (44%) were women, and 160 (52%) were white. For the ranibizumab and PRP groups, the mean (SD) number of injections over 5 years was 19.2 (10.9) and 5.4 (7.9), respectively; the mean (SD) change in visual acuity letter score was 3.1 (14.3) and 3.0 (10.5) letters, respectively (adjusted difference, 0.6; 95% CI, -2.3 to 3.5; P = .68); the mean visual acuity was 20/25 (approximate Snellen equivalent) in both groups at 5 years. The mean (SD) change in cumulative visual field total point score was -330 (645) vs -527 (635) dB in the ranibizumab (n = 41) and PRP (n = 38) groups, respectively (adjusted difference, 208 dB; 95% CI, 9-408). Vision-impairing diabetic macular edema developed in 27 and 53 eyes in the ranibizumab and PRP groups, respectively (cumulative probabilities: 22% vs 38%; hazard ratio, 0.4; 95% CI, 0.3-0.7). No statistically significant differences between groups in major systemic adverse event rates were identified. CONCLUSIONS AND RELEVANCE: Although loss to follow-up was relatively high, visual acuity in most study eyes that completed follow-up was very good at 5 years and was similar in both groups. Severe vision loss or serious PDR complications were uncommon with PRP or ranibizumab; however, the ranibizumab group had lower rates of developing vision-impairing diabetic macular edema and less visual field loss. Patient-specific factors, including anticipated visit compliance, cost, and frequency of visits, should be considered when choosing treatment for patients with PDR. These findings support either anti-vascular endothelial growth factor therapy or PRP as viable treatments for patients with PDR. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01489189.

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Published In

JAMA Ophthalmol

DOI

EISSN

2168-6173

Publication Date

October 1, 2018

Volume

136

Issue

10

Start / End Page

1138 / 1148

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Tomography, Optical Coherence
  • Ranibizumab
  • Middle Aged
  • Male
  • Laser Coagulation
  • Intravitreal Injections
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Gross, J. G., Glassman, A. R., Liu, D., Sun, J. K., Antoszyk, A. N., Baker, C. W., … Diabetic Retinopathy Clinical Research Network, . (2018). Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA Ophthalmol, 136(10), 1138–1148. https://doi.org/10.1001/jamaophthalmol.2018.3255
Gross, Jeffrey G., Adam R. Glassman, Danni Liu, Jennifer K. Sun, Andrew N. Antoszyk, Carl W. Baker, Neil M. Bressler, et al. “Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.JAMA Ophthalmol 136, no. 10 (October 1, 2018): 1138–48. https://doi.org/10.1001/jamaophthalmol.2018.3255.
Gross JG, Glassman AR, Liu D, Sun JK, Antoszyk AN, Baker CW, et al. Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Oct 1;136(10):1138–48.
Gross, Jeffrey G., et al. “Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.JAMA Ophthalmol, vol. 136, no. 10, Oct. 2018, pp. 1138–48. Pubmed, doi:10.1001/jamaophthalmol.2018.3255.
Gross JG, Glassman AR, Liu D, Sun JK, Antoszyk AN, Baker CW, Bressler NM, Elman MJ, Ferris FL, Gardner TW, Jampol LM, Martin DF, Melia M, Stockdale CR, Beck RW, Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Oct 1;136(10):1138–1148.

Published In

JAMA Ophthalmol

DOI

EISSN

2168-6173

Publication Date

October 1, 2018

Volume

136

Issue

10

Start / End Page

1138 / 1148

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Tomography, Optical Coherence
  • Ranibizumab
  • Middle Aged
  • Male
  • Laser Coagulation
  • Intravitreal Injections
  • Humans