Laird Harrison

July 17, 2015

VIENNA — Pigment epithelial detachments of any size can be effectively treated with low-dose ranibizumab (Lucentis, Genentech) in patients with subfoveal neovascular age-related macular degeneration, according to an analysis of data from the phase 3 HARBOR study.

Even when the dose of the VEGF inhibitor was quadrupled, "no additional benefit was seen," said David Eichenbaum, MD, from Retina Vitreous Associates of Florida in Clearwater.

Dr Eichenbaum presented the findings here at the American Society of Retina Specialists (ASRS) 2015 Annual Meeting.

Pigment epithelial detachments, especially large ones, can complicate the treatment of neovascular macular degeneration, he explained.

In the HARBOR study, the 1097 treatment-naive patients with subfoveal age-related macular degeneration were treated with one of four intravitreal ranibizumab regimens: 0.5 or 2.0 mg monthly for 24 months or 0.5 or 2.0 mg monthly for 3 months, then as needed for the remaining 21 months on the basis of visual acuity and spectral domain optical coherence tomography.

Dr Eichenbaum and colleagues analyzed data on the 598 HARBOR patients who had pigment epithelial detachments. Detachments were categorized by vertical height as small (35 - 164 μm), medium (164.5 - 233 μm), large (233.25 - 351 μm), or extra-large (352 - 1395.5 μm).

Regardless of whether the patients had pigment epithelial detachments at baseline or they developed later, ranibizumab rapidly improved best corrected visual acuity.

In addition, for the patients with detachments at baseline, mean thickness decreased rapidly.

At 24 months, there was no significant difference in outcome with the different treatment regimens, even in patients with extra-large pigment epithelial detachments.

However, there was a slightly larger decrease in thickness of the extra-large detachments in the 2-mg treatment groups.

Table. Mean Change From Baseline to 24 Months

Outcome 0.5 mg monthly (n = 37) 2 mg monthly (n = 35) 0.5 mg as needed (n = 43) 2 mg as needed (n = 35)
Detachment thickness, μm −160.9 −195.5 −163.5 −190.7
Extra-large detachment        
 Thickness, μm −249.6 −354.3 −270.1 −380.5
 Visual acuity, letters 6.4 −0.8 5.3 7.7

For patients with extra-large detachments in the as-needed groups, injection frequency with the 0.5- and 2-mg doses was comparable.

At 24 months, the rate of macular atrophy was higher in eyes with complete flattening of the detachment than in those without complete flattening.

There was no association between macular atrophy and detachment size; however, the majority of retinal pigment tears occurred in patients with extra-large detachments, Dr Eichenbaum reported.

After the presentation, an audience member asked whether any patients did not respond at all to ranibizumab and whether their regimen was changed.

"There were indeed patients who did not respond," Dr Eichenbaum explained, but in the HARBOR study, "the patients remained on the protocol."

The audience member also wanted to know whether ranibizumab is the best treatment for pigment epithelial detachments. "I use all three antiangiogenic agents," Dr Eichenbaum said, "but I think ranibizumab works well."

Another person asked whether the researchers had compared serous with vascular detachments.

"In HARBOR, there was not a subclassification," Dr Eichenbaum responded, "but I agree it would be interesting to subclassify."

Such a subclassification is key, said session moderator Susanne Binder, MD, from the Rudolf Foundation Clinic at the Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery in Vienna.

"You need to differentiate," she told Medscape Medical News. "More severe disease is actually vascularized."

The take-home message is that ranibizumab is "good enough" to treat pigment epithelial detachments, Dr Binder explained. This is important because so many clinicians now favor aflibercept.

Dr Eichenbaum reports financial relationships with Allergan, Genentech, Hemera Biopharmaceuticals, and US Retina. Dr Binder reports a relationship with Carl Zeiss.

American Society of Retina Specialists (ASRS) 2015 Annual Meeting. Presented July 13, 2015.


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