VEGF Inhibition Improves Visual Acuity in Macular Edema

Neil Osterweil

April 12, 2014

TOKYO — Ranibizumab (Lucentis, Genentech, Inc) is associated with significant improvement in visual acuity in patients with macular edema secondary to branch retinal vein occlusion, a new study shows.

Improvement was seen whether or not the patients underwent laser photocoagulation.

The change in best corrected visual acuity (BCVA) from baseline to 6 months was similar in patients treated with ranibizumab plus laser therapy and in those treated with ranibizumab alone, said Ramin Tadayoni, MD, an ophthalmologist at the Lariboisière Hospital in Paris, France. Both groups improved significantly more than patients treated with laser therapy alone.

"The study showed that ranibizumab can be used in ischemic cases and in nonischemic cases, and there were no new safety concerns," Dr. Tadayoni reported here at the World Ophthalmology Congress 2014.

Ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, was approved in 2010 by the US Food and Drug Administration for visual impairment from retinal vein occlusion on the basis of data from the BRAVO study, which involved patients with branch retinal vein occlusion, and the CRUISE study, which involved patients with central retinal vein occlusion.

Dr. Tadayoni and colleagues evaluated long-term efficacy and safety data for ranibizumab in patients with branch retinal vein occlusion in the Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion (BRIGHTER) trial.

The open-label, multicenter study involved 455 patients with visual loss from macular edema secondary to branch retinal vein occlusion. After a 14-day screening period, 183 patients were assigned to treatment with ranibizumab 0.5 mg, 180 were assigned to treatment with ranibizumab plus adjunctive laser photocoagulation, and 92 were assigned to treatment with laser alone.

Patients assigned to ranibizumab underwent monthly intravitreal injections in the study eye until stable visual acuity had been achieved for 3 consecutive months. Thereafter, ranibizumab was administered as needed, on the basis of visual acuity.

Patients assigned to laser therapy underwent treatment as soon as indicated, which was repeated at minimum intervals of 4 months. Laser treatments were not administered if no macular edema was present or if the patient had a BCVA of at least 79 ETDRS letters.

Patients in the laser monotherapy group could cross over to receive ranibizumab after 6 months.

Approximately a quarter of patients in each group had ischemic branch retinal vein occlusion. The mean duration of occlusion was 10.3 months in the ranibizumab monotherapy group, 9.3 months in the combination group, and 10.5 months in the laser monotherapy group.

Although most baseline characteristics were well balanced, by chance, patients in the ranibizumab monotherapy group had better baseline visual acuity; 60% had a BCVA of at least 60 letters, compared with approximately 47% in the other 2 groups.

At 6 months, ranibizumab monotherapy was associated with a mean gain in BCVA of 14.8 letters, and the combination was associated with a mean gain of 14.1 letters. In contrast, laser monotherapy was associated with a mean gain of 6.0, a difference that was statistically significant, compared with the 2 ranibizumab groups (P < .0001).

Adverse ocular effects led to the discontinuation of study treatment in 3 patients — 1 in the ranibizumab monotherapy group and 2 in the combination group. One patient who received ranibizumab monotherapy died of respiratory failure, but the death was judged to be unrelated to the study.

Patients with investigator-judged ischemia fared better in all groups than patients with no ischemia.

"Surprisingly, branch retinal vein occlusion with ischemia may do better with treatment, even laser, than nonischemic cases," Dr. Tadayoni reported. "I don't have an explanation for this, but the fact that ischemic cases were included is not an explanation for the results; ischemic cases can be treated with ranibizumab, as other cases are," he said.

One possible flaw in the study is that ischemia was judged by participating physicians. "The problem is that there's no really good standardization of ischemia in vein occlusion," said Adnan Tufail, MD, consultant ophthalmologist at Moorfields Eye Hospital in London, United Kingdom, who was not involved in the study.

In addition, Dr. Tufail questioned whether patients with ischemia might have had greater macular thickness and poorer visual acuity at baseline, which could have confounded the results. Dr. Tadayoni acknowledged that they had not looked at that issue yet.

The BRIGHTER study was supported by Novartis. Dr. Tadayoni reports consulting and lecturing for the company. Dr. Tufail reports serving on an advisory board and consulting for Novartis.

World Ophthalmology Congress (WOC) 2014: Abstract FP-FR-20-7. Presented April 4, 2014.

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