Take-home message: Patients with branch retinal vein occlusion had better visual outcomes and decreased macular edema following intravitreal injection of aflibercept compared with laser treatment.
By Lynda Charters; Reviewed by Jennifer I. Lim, MD
—Rescue treatment with intravitreal aflibercept (Eylea, Regeneron Pharmaceuticals) provides significant visual benefits in patients treated with grid laser for macular edema associated with branch retinal vein occlusion (BRVO) at week 52 of the VIBRANT Study, said Jennifer Lim, MD.
The VIBRANT Study was a 52-week, phase III trial in which 183 eyes with BRVO with macular edema were randomized to either 2 mg of intravitreal aflibercept every 4 weeks beginning at baseline for 24 weeks (n = 91 eyes) or grid laser treatment at baseline (n = 92 eyes), explained Dr. Lim, director of retina, Marion H. Schenk Chair and professor of ophthalmology, Illinois Eye and Ear Infirmary, University of Illinois at Chicago.
The primary endpoint at 24 weeks was the percentage of patients with a three-line increase (15 letters or more) in visual acuity (VA).
The secondary endpoints were the mean changes in the best-corrected VA (BCVA) and the central retinal thickness (CRT). At 24 weeks, the eyes treated with intravitreal aflibercept received 2 mg of the drug every 8 weeks and rescue laser if needed at 36 weeks. The eyes that were randomly assigned to laser were treated with rescue intravitreal aflibercept if needed.
These eyes received 2 mg of intravitreal aflibercept rescue therapy every 8 weeks following 3 monthly doses of intravitreal aflibercept.
To qualify for this treatment, the patients must have had a greater than 50-μm increase from lowest previous CRT, new or persistent cystic retinal changes or subretinal fluid or persistent diffuse edema in the central subfield, and loss of 5 or more letters from the best previous measurement with any increase in CRT.
Dr. Lim reported that intravitreal aflibercept was almost twice as effective at the 24-week time point compared with grid laser therapy. This difference was highly significant (p
At the 52-week evaluation, more patients who were treated with intravitreal aflibercept achieved VA increases of 15 or more letters compared with those treated with laser, a difference that also reached significance (p
= 0.0296), according to Dr. Lim.
About half of the study patients experienced an adverse event, 47.8% in the laser with intravitreal aflibercept rescue group and 49.5% in the intravitreal aflibercept group that initially received the drug every 4 weeks and then every 8 weeks.
The vast majority of adverse events were conjunctival hemorrhages followed by ocular pain and irritation. All of the thromboembolic events and a death occurred in the original laser with intravitreal aflibercept rescue as needed group. One patient each had a nonfatal stroke that occurred before receiving any intravitreal aflibercept rescue and a nonfatal myocardial infarction, and one death from pneumonia occurred during the first 6 months of the study before the patient was treated with aflibercept.
Laser subgroup analysis
The investigators conducted a subgroup analysis of the patients in the laser group who were treated with intravitreal aflibercept if they met the criterion. Eligible patients were treated with intravitreal aflibercept every 8 weeks after having been treated with 3 monthly injections of the drug if they met the rescue criterion beginning at week 24, Dr. Lim explained.
Among the patients in the laser group, by week 52, more than three quarters of the 83 patients who completed 24 weeks of the study received intravitreal aflibercept rescue therapy. The median time to the first rescue injection from baseline was 24.9 weeks (range, 23.1-48.4). Patients received a mean of 4.4 intravitreal injections.
A look at the results at 24 weeks in the laser group showed that the laser and intravitreal aflibercept-treated patients received a slightly higher mean number of laser treatments compared with the patients who received only laser treatment.
In the laser group at 24 weeks, more patients treated with laser only gained 15 or more letters of VA compared with those who were subsequently treated with laser and intravitreal aflibercept. However, with intravitreal aflibercept rescue, at 52 weeks, the number of patients achieving a 15 or greater gain in letters was closer to that in the laser only group.
A decrease in the CRT was seen along with the increase in the VA. The CRT decreased substantially more in the laser and intravitreal aflibercept group at 52 weeks compared with the laser only group.
“Overall intravitreal aflibercept was superior to laser treatment through week 24 for VA and anatomic outcomes,” Dr. Lim said.
Jennifer I. Lim, MD
E: [email protected]
Dr. Lim is on the advisory boards and speaker’s bureaus of Genentech Inc. and Regeneron Pharmaceuticals.