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Dennis M Marcus, ; Evaluation of Rescue Treatment with Intravitreal Aflibercept Injection (IAI) in Patients with Diabetic Macular Edema (DME) Randomized to Laser in the VISTA and VIVID Studies. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1763.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the use of IAI rescue treatment and outcomes over 2 years in patients randomized to laser control.
VISTA and VIVID were double-masked, phase 3 trials randomizing 466 and 406 DME patients, respectively, to receive either IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks (2q8, following 5 initial monthly doses), or laser. Rescue was available to patients beginning at week 24 if pre-defined rescue criteria were met. Qualifying patients in the laser group received IAI 2 mg every 8 weeks (following 5 monthly doses). For the primary endpoint, mean change from baseline in best-corrected visual acuity (BCVA) at week 52, the analysis was conducted using last observation carried forward (LOCF), excluding measurements obtained after initiation of rescue. Another analysis was performed which included measurements after rescue was initiated (aLOCF).
Mean BCVA gain from baseline to week 100 (LOCF) in the 2q4, 2q8 and laser group was 11.5, 11.1 and 0.9 letters (P<0.0001) in VISTA, and 11.4, 9.4 and 0.7 letters (P<0.0001) in VIVID. By Week 100, 63 (40.9%) and 46 (34.6%) of laser patients received rescue in VISTA and VIVID, respectively. When measurements after IAI rescue treatment were included (aLOCF), mean BCVA change from baseline at Week 100 for the entire laser group was 6.3 and 5.5 letters in VISTA and VIVID, respectively. Mean BCVA change from baseline to week 100 was 2.2 and 3.8 letters in VISTA and VIVID, respectively in rescued patients. The most frequent ocular serious adverse event was vitreous hemorrhage in VISTA (1.3%, 0.7% and 1.9% for 2q4, 2q8 and laser) and cataract in VIVID (2.2%, 2.2%, and 0% for 2q4, 2q8 and laser).
A considerable proportion of patients randomized to laser required rescue with IAI in both studies. Due to visual acuity loss occurring before rescue was given, these patients did not achieve vision outcomes at Week 100 similar to the entire laser group or those randomized to the IAI group from baseline. Early treatment with IAI is recommended in patients with DME.
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