July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Treatment of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy with Intravitreal Aflibercept Injection: 52-Week Results from the Phase 3 PANORAMA Study
Author Affiliations & Notes
  • David S Boyer
    Ophthalmology, Retina Vitreous Assoc Med Group, Los Angeles, California, United States
  • Footnotes
    Commercial Relationships   David Boyer, Aerpio (C), Allegro (C), Allergan (C), Bayer (C), Eyepoint (C), Genentech (C), Novartis (C), Regeneron (C), Roche (C), Santen (C), TLC (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 1731. doi:
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      David S Boyer; Treatment of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy with Intravitreal Aflibercept Injection: 52-Week Results from the Phase 3 PANORAMA Study. Invest. Ophthalmol. Vis. Sci. 2019;60(9):1731.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : In VISTA and VIVID, significantly more patients with diabetic macular edema (DME) who received intravitreal aflibercept injection (IAI) achieved a ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score than those who received laser photocoagulation. PANORAMA investigated the efficacy and safety of treatment with IAI versus sham in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) in patients without DME.

Methods : PANORAMA is a phase 3, double-masked, randomized clinical trial (ClinicalTrials.gov NCT02718326). Patients ≥18 years old with diabetes mellitus type 1 or 2 were eligible to enroll if they met the following criteria: presence of moderately severe to severe NPDR (DRSS levels 47 or 53), absence of CI-DME, and baseline best-corrected visual acuity (BCVA) of ≥69 letters (approximately ≥20/40) in the study eye. A total of 402 patients were randomized to receive either IAI 2 mg administered every 8 weeks following five monthly doses (2q8, n=134), IAI 2 mg administered every 16 weeks following three monthly doses and one eight-week interval (2q16, n=135), or sham (n=133) through week 52. The primary endpoint was the proportion of patients with a ≥2-step improvement in DRSS score at week 52.

Results : Overall, 44.0% of patients were female, with a mean (SD) age of 55.7 (10.5) years and a mean (SD) BCVA of 82.4 (6.0) letters at baseline. IAI 2q8 and IAI 2q16 patients received a mean of 8.6 and 5.5 injections through week 52, respectively. The proportion of patients with a ≥2-step improvement in DRSS score was significantly greater with IAI 2q8 and IAI 2q16 versus sham at week 52 (80% and 65% versus 15%, P<0.0001 for both). The proportion of patients who developed vision-threatening complications (proliferative diabetic retinopathy/anterior segment neovascularization) was significantly lower with IAI 2q8 and IAI 2q16 compared with sham (3% and 4% versus 20%, P<0.001 for both). The incidence of center-involved DME was also significantly lower with IAI 2q8 and IAI 2q16 compared with sham (8% and 7% versus 26%, P<0.001 for both). No new safety signals were identified with IAI.

Conclusions : These findings suggest that treatment with IAI may reverse disease progression in patients diagnosed with moderately severe to severe NPDR.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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