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Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.

Publication ,  Journal Article
Antoszyk, AN; Glassman, AR; Beaulieu, WT; Jampol, LM; Jhaveri, CD; Punjabi, OS; Salehi-Had, H; Wells, JA; Maguire, MG; Stockdale, CR; Sun, JK ...
Published in: JAMA
December 15, 2020

IMPORTANCE: Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown. OBJECTIVE: To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020. INTERVENTIONS: Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria. MAIN OUTCOMES AND MEASURES: The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years. RESULTS: Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept. CONCLUSIONS AND RELEVANCE: Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02858076.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

December 15, 2020

Volume

324

Issue

23

Start / End Page

2383 / 2395

Location

United States

Related Subject Headings

  • Vitreous Hemorrhage
  • Vitrectomy
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Retina
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Postoperative Complications
  • Middle Aged
 

Citation

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Antoszyk, A. N., Glassman, A. R., Beaulieu, W. T., Jampol, L. M., Jhaveri, C. D., Punjabi, O. S., … DRCR Retina Network, . (2020). Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA, 324(23), 2383–2395. https://doi.org/10.1001/jama.2020.23027
Antoszyk, Andrew N., Adam R. Glassman, Wesley T. Beaulieu, Lee M. Jampol, Chirag D. Jhaveri, Omar S. Punjabi, Hani Salehi-Had, et al. “Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.JAMA 324, no. 23 (December 15, 2020): 2383–95. https://doi.org/10.1001/jama.2020.23027.
Antoszyk AN, Glassman AR, Beaulieu WT, Jampol LM, Jhaveri CD, Punjabi OS, Salehi-Had H, Wells JA, Maguire MG, Stockdale CR, Martin DF, Sun JK, DRCR Retina Network. Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2020 Dec 15;324(23):2383–2395.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

December 15, 2020

Volume

324

Issue

23

Start / End Page

2383 / 2395

Location

United States

Related Subject Headings

  • Vitreous Hemorrhage
  • Vitrectomy
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Retina
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Postoperative Complications
  • Middle Aged