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Michael Javaheri, Lauren Hill, Avanti Ghanekar, Ivaylo Stoilov; Pigment Epithelial Detachments Response to a Single Ranibizumab Injection: a HARBOR Subanalysis. Invest. Ophthalmol. Vis. Sci. 2019;60(9):75. doi: https://doi.org/.
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The phase 3 HARBOR trial (NCT00891735) enrolled 1098 treatment naïve patients with subfoveal wet age-related macular degeneration (wAMD). Of these, 53% had pigment epithelial detachment (PED) at baseline. We examined the changes in PED status after one ranibizumab injection.
In HARBOR, patients received 3 consecutive monthly loading injections of RBZ 0.5 or 2.0 mg, then as-needed (PRN) or monthly treatment through month (M)24. This study examines 586 eyes from HARBOR with PED at baseline (BL), noting PED response after 1 loading dose (0.5/2.0 mg pooled). BL PED height was examined for flat vs present PEDs after a single injection. PEDs were grouped into quartiles based on height at BL, and mean thickness was evaluated. PED status (present/absent) was assessed at M1 and M2. Patient characteristics including drusen status, RBZ dose regimen, and total number of injections were examined.
After only one ranubizumab injection, 35.5% (208/586) of patients with PED at BL had PED flattened. Importantly, 92.3% (191/208) of these patients maintained a flat PED through M2. Of the patients with PED present at M1, an additional 17.3% (64/378) had flat PED after receiving a second injection. PED thickness at BL was significantly different between subjects with PED present (319.9 µm) or flat (206.0 µm) at M1 (P < 0.0001). Of 208 eyes with flat PED at M1, 38.9% (81) were from the small PED quartile (35–164 µm) vs 31.7% (66), 19.2% (40), and 10.1% (21) in the medium (164.5–233 µm), large (233.25–351 µm), and X-large (352–1395.5 µm) quartiles, respectively. Drusen characteristics (soft/hard and number) were not associated with PED response at M1. Of patients with flat PED at M1, 57.7% (120/208) were in the RBZ 2.0 mg arm and 42.3% (88/208) in the 0.5 mg arm. In the PRN arms, patients with PED present at M1 required a greater mean number of RBZ injections (14.2) vs those with flat PED at M1 (11.0) by M24 (P < 0.0001).
The present study shows that most patients achieving a flat PED after a single RBZ injection maintained flat PEDs through M2. Smaller PED thickness at BL and higher RBZ dose were associated with PED flattening at M1, however, drusen characteristics (soft/hard and number) were not associated with PED response.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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