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David M Brown; Intravitreal Aflibercept Injection (IAI) for Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR): The Phase 3 PANORAMA Study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1889.
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To evaluate efficacy and safety of IAI for treatment of patients with moderately severe to severe NPDR.
PANORAMA is a double-masked, randomized, phase 3 clinical trial. Patients ≥18 years of age with type 1 or 2 diabetes mellitus were eligible for enrollment if they had moderately severe to severe NPDR (Diabetic Retinopathy Severity Scale [DRSS] levels 47 to 53) without diabetic macular edema (DME) and who could safely defer panretinal photocoagulation for at least 6 months. Baseline best-corrected visual acuity (BCVA) ETDRS letter score had to be ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the study eye. Patients were randomized in a 1:1:1 ratio to receive IAI 2 mg q8 weeks after five initial monthly doses (2q8), IAI 2 mg q16 weeks after three initial monthly doses and one 8-week interval (2q16), or sham injections through week 48. The primary outcome measure is the proportion of patients who had ≥2-step improvement in the DRSS score from baseline at weeks 24 and 52.
Enrollment in the PANORAMA study is complete with 402 patients participating from 5 countries (United States, Japan, Germany, Hungary, and United Kingdom). Mean (SD) age at baseline is 55.7 (10.5) years. Overall, 44.0% of patients are women, and 56.0% are men. Primary results through week 24 will be presented.
Results from this first phase 3 study using an anti-VEGF agent for the treatment of moderately severe to severe NPDR, in patients without DME, will provide insight into the role of IAI therapy in the management of this disease.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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