• Diabetes Mellitus Retinal Diseases
• Ophthalmology Clinical Trials

• Diabetes Mellitus
• Ophthalmology
• Retinal Diseases
• Ophthalmology Clinical Trials

Quan Dong Nguyen, MD, MSc, University of Nebraska Medical Center, Omaha, Nebraska, USA, described the 2-year outcomes of the Intravitreal Alfibercept Injection in Vision Impairment Due to DME [VIVID; NCT01331681] trial as well as the Study of Intravitreal Administration of VEGF Trap-Eye (BAY86-5321) in Patients With Diabetic Macular Edema [VISTA; NCT01363440]. VIVID and VISTA are both phase III, randomized, double-blind global studies in which intravitreal aflibercept was injected to treat diabetic macular edema (DME).

VIVID was a 73-center study involving 406 patients; VISTA enrolled 466 patients at 54 centers. Patients with clinically significant DME and eye chart-rated best corrected visual acuity (BCVA) of 20/40 to 20/320 were randomized in a 1:1:1 fashion to receive injections of intravitreal aflibercept 2 mg every 4 weeks (2Q4; n = 136 in VIVID and n = 154 in VISTA), 2 mg every 8 weeks (2Q8; n = 135 in VIVID and n = 151 in VISTA), or the control procedure of laser photocoagulation (n = 132 in VIVID and n = 154 in VISTA). The primary end point of mean change in BCVA was assessed at week 52, with treatment and assessment continued through year 3. Key secondary end points included change in optical coherence tomography and change in the diabetic retinopathy severity scale (DRSS).

At baseline, patients' age, sex, race, mean level of glycated hemoglobin, duration of diabetes, and body mass index were similar in the 3 arms of both studies. Baseline disease characteristics of BCVA and central retinal thickness were also similar between the study arms. Prior treatment with anti-vascular endothelial growth factor medication was more variable and higher in VISTA participants.

In VIVID, the week 100 completion rates were 77.8%, 84.6%, and 81.5% for the control, 2Q4, and 2Q8 arms, respectively, with an overall completion rate of 81.3%. The respective values for the 3 arms of the VISTA trial were 85.3%, 80.1%, and 82.5%, with an overall completion rate of 82.6%.

Through week 100, the mean number of laser treatments was 2.4 in VIVID and 3.5 in VISTA. The mean numbers of injections in the 2Q4 and 2Q8 arms were 22.6 and 13.6, respectively, in VIVID and 21.3 and 13.5, respectively, in VISTA. Rescue treatment was necessary in 34.6%, 7.4%, and 11.1% of the VIVID patients in the control, 2Q4, and 2Q8 arms, respectively, and 40.9%, 3.2%, and 8.6% of the VISTA patients in the respective arms.

In both trials, the significant improvement in BCVA noted at 4 weeks was maintained through week 100 (P < .001 for both trials).

Gain of BCVA of ≥ 10 and ≥ 15 letters at week 100 was significant for the 2Q4 and 2Q8 arms in VIVID (58.1% and 49.6%, and 38.2% and 31.1%, respectively) compared with the control (25.0% and 12.1%) and in VISTA (63.6% and 59.6%, and 38.3% and 33.1%, respectively) compared with the control (27.9% and 13.0%). The improvements in the treatment arms were similar. The mean change in retinal thickness through week 100 in both trials significantly favored both treatments compared with the control (both P < .001).

In both trials, there was a higher proportion of patients in the treatment arms with ≥ 2-step improvement in DRSS at week 100 compared with the control arms. The safety profile in both trials was acceptable, with no treatment-related ocular adverse events or systemic serious adverse events, no increased rate of arterial thrombotic events, and no safety signals related to death.

The week 100 findings demonstrate the effectiveness of intravitreal aflibercept in the treatment of DME and confirm the safety of both treatment regimens.

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