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Arshad Khanani, Lauren Hill, Lisa Tuomi; Improvement in visual acuity following ranibizumab treatment in neovascular age-related macular degeneration patients with large pigment epithelial detachments: a subgroup analysis of the HARBOR study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5363.
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© ARVO (1962-2015); The Authors (2016-present)
Retinal pigment epithelial detachments (PEDs), especially large PEDs, are challenging to manage in patients with neovascular age-related macular degeneration. An exploratory subgroup analysis was undertaken to evaluate the effect of ranibizumab (RBZ) treatment on large PEDs over 2 years.
In HARBOR, 1097 patients were randomized to receive 3 consecutive monthly doses of intravitreal RBZ 0.5 mg or 2.0 mg. Patients then either continued on monthly therapy or were re-treated PRN based on visual acuity and strict SD-OCT criteria. Patients’ best-corrected visual acuity (BCVA), change in BCVA from baseline, resolution of PED, reduction in PED thickness, and number of injections in the PRN treatment groups were evaluated over 24 months. Vertical height of PEDs ranged from ~35-1400 µm on SD-OCT at baseline and results were summarized using quartiles based on baseline PED thickness. The current analysis defined large PEDs as those in the largest PED quartile (≥352 µm).
In total, 150 (25.1%) of the 598 patients with a PED at baseline had a large PED. Mean change from baseline in BCVA at Month 24 (M24) was +6.4 and +5.3 letters in patients with large PEDs who received 0.5 mg monthly or PRN, respectively. No additional vision benefit was seen in patients with large PEDs who received 2.0 mg monthly or PRN (mean change in vision at M24: -0.8 and +7.7 letters, respectively). In the PRN arms, injection frequency was similar for patients with large PED present at baseline who received either 0.5 mg (15.6 injections) or 2.0 mg (14.3 injections). Complete resolution of large PEDs at M24 was noted in 25.0% and 29.7% of patients who received 0.5 mg RBZ monthly or PRN, respectively. In the 2.0 mg monthly and PRN groups, large PEDs completely resolved in 53.3% and 40.6% of patients, respectively. There was a slightly greater decrease in PED thickness at M24 in the 2.0 mg arms (0.5 mg: monthly -257.32 µm, PRN -277.43 µm; 2.0 mg: monthly -349.3 µm, PRN -387.5 µm).
Significant improvements in vision were seen with RBZ 0.5 mg in patients with large PEDs at baseline. No additional vision benefit was seen with the 2.0 mg dose. These results suggest that RBZ 0.5 mg given monthly or PRN effectively manages large PEDs and results in clinically significant vision gains over 2 years.
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