Ranibizumab Treatment for Pigment Epithelial Detachment Secondary to Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study

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• 作者：David Sarraf ; MD¹ ; ² ; ^{dsarraf@ucla.com" class="auth_mail" title="E-mail the corresponding author} ; Nikolas J.S. London ; MD³ ; Rahul N. Khurana ; MD⁴ ; ⁵ ; Pravin U. Dugel ; MD⁶ ; Shamika Gune ; MD⁷ ; Lauren Hill ; MS⁷ ; Lisa Tuomi ; PharmD⁷
• 关键词：AMD ; age-related macular degeneration ; BCVA ; best-corrected visual acuity ; CNV ; choroidal neovascularization ; ETDRS ; Early Treatment Diabetic Retinopathy Study ; HARBOR ; Phase III ; Double-Masked ; Multicenter ; Randomized ; Active Treatment-Controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-Needed Basis (PRN) in Patients with Subfoveal Neovascular Age-Related Macular Degeneration ; OCT ; optical coherence tomography ; PED ; pigment epithelial de
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：123
• 期：10
• 页码：2213-2224
• 全文大小：1323 K

文摘

To analyze the effect of baseline presence and height of pigment epithelial detachments (PEDs) on visual and anatomic outcomes at 24 months in patients with neovascular age-related macular degeneration (AMD) treated with ranibizumab.

Design

Post hoc analysis of HARBOR, a 24-month, phase III, randomized, multicenter, double-masked, active treatment–controlled study (clinicaltrials.gov identifier, NCT00891735).

Participants

One thousand ninety-seven patients with neovascular AMD.

Methods

Intravitreal ranibizumab 0.5 mg or 2.0 mg monthly or pro re nata (PRN) after 3 monthly loading doses.

Main Outcome Measures

We evaluated the effect of presence and height of baseline PED on several outcomes at 24 months, including best-corrected visual acuity (BCVA), change in PED height, resolution of PED, and number of injections in the PRN arms. Development of macular atrophy at month 24 by presence or absence of PED was evaluated.

Results

Five hundred ninety-eight (54.5%) patients showed PED at baseline. In the ranibizumab 0.5-mg PRN group, mean numbers of injections were similar for patients with PED present or absent at baseline (14.0 vs. 12.5). Mean BCVA gains from baseline to 24 months were seen in all treatment groups and were comparable in patients with or without PED at baseline treated with ranibizumab 0.5 mg monthly (PED present at baseline, +9.0 letters; PED absent at baseline, +11.3 letters), 0.5 mg PRN (present, +8.4; absent, +7.9), 2.0 mg monthly (present, +7.1; absent, +11.1), or 2.0 mg PRN (present, +7.2; absent, +8.8). When analyzed by baseline PED height, mean BCVA gains were demonstrated and comparable in all treatment groups at 24 months except for patients treated with ranibizumab 2.0 mg monthly in the extra-large group (PEDs ≥352 μm; mean BCVA change, −0.8 letters). At 24 months, 53.2% (0.5 mg monthly), 44.5% (0.5 mg PRN), 70.4% (2.0 mg monthly), and 57.3% (2.0 mg PRN) of patients showed complete resolution of PED.

Conclusions

Ranibizumab 0.5 mg given monthly or PRN effectively treated PEDs in patients with neovascular AMD, and significant vision gains resulted regardless of PED status and height at baseline. In this analysis, there was no additional vision benefit with a higher dose of ranibizumab (2.0 mg).