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Fareed A. Ali, Eric Tourville, John C. Chen, Peter J. Kertes, Bonita Rehel, Frederica De Takacsy, Ruihong Li; Spectral-Domain OCT Monitoring in Patients with Choroidal Neovascularization Secondary to Age-related Macular Degeneration, a Lucentis Outcomes Pilot Program (HOLOGRAM): 12-month results. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2923.
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The study’s objective was to compare the real-life effectiveness of Lucentis treatment as monitored by Spectral-Domain Optical Coherence Tomography (SD-OCT) versus Time-Domain Optical Coherence Tomography (TD-OCT) in the management of patients with wet AMD.
In a prospective, open-label, multicenter, Canadian, Phase IV study, a total of 91 patients with wet AMD were enrolled to receive intravitreal Lucentis treatment for 12 months. Patients were monitored by either SD-OCT (SD arm) or TD-OCT (TD arm) and re-treatment decisions were made based on OCT findings. The primary endpoint was the comparison of the mean change from baseline to 12 months in Best-Corrected Visual Acuity (BCVA) between the two arms.
Among the 91 patients, 70 were assigned to the SD arm and 21 to the TD arm. All 91 patients were included in the Intent-To-Treat (ITT) population. Seventy-five (75) patients (82.4%) completed the 12 month study. The demographics between the two arms are comparable. After 12 months of treatment with Lucentis, the mean change from baseline in BCVA was an increase of 7.8 (95% CI: 3.4, 12.2) ETDRS letters in the SD arm, and 5.3 (95% CI: -3.4, 14.0) letters in the TD arm. The mean reduction in Central Retinal Thickness (CRT) from baseline to month 12 was 82.7 µm (95% CI: -109.1, -56.3) and 72.5 µm (95% CI: -164.8, 19.7) in the SD and TD arms, respectively. The percentage of patients gaining 15 letters or more from baseline to month 12 was 34.7% for the SD arm and 23.1% for the TD arm. The mean number of Lucentis treatments administered was 7.1 (SD arm) and 6.0 (TD arm).
Intravitreal Lucentis treatment with OCT monitoring improved visual acuity over 12 months with marginally superior results for SD-OCT compared to TD-OCT monitoring. The PRN treatment regimen of Lucentis based on OCT findings demonstrated an effective real-world management in patients with wet AMD.
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