Original article
Effects of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Attributable to Age-related Macular Degeneration

https://doi.org/10.1016/j.ajo.2008.12.005Get rights and content

Purpose

To demonstrate not only prevention of vision loss but also improvement in best-corrected visual acuity (BCVA) after treatment with ranibizumab on a variable-dosing regimen over 24 months in patients with age-related macular degeneration (AMD).

Design

Interventional case series.

Methods

setting: Institutional. study population: One hundred and thirty-eight eyes of 138 patients treated intravitreally with 0.5 mg ranibizumab (Lucentis; Novartis, Basel, Switzerland). Age above 50 years, BCVA 0.2 to 1.2 logarithm of the minimal angle of resolution (logMAR), primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD. observation procedures: After single initial treatment, monthly follow-up examination. Retreatment in case of one of the following: sign of subretinal fluid or intraretinal edema, increase in central retinal thickness (CRT) on optical coherence tomography (OCT), active CNV on fluorescein angiography, increase of metamorphopsia, and loss of BCVA >5 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. main outcome measures: Compared with baseline: proportion of eyes gaining ≥15 letters, proportion of eyes losing or gaining <15 letters, change in CRT.

Results

After 24 months, 30% of eyes gained ≥15 letters. After 24 months, 55% of eyes lost or gained <15 letters. Mean CRT of 386 ± 145 μm at baseline was significantly reduced to 211 ± 39 μm after 24 months (P = .036). Mean injection number per patient was 5.6 ± 2.9 and 4.3 ± 3.8 from baseline to month 12 and month 12 to 24, respectively.

Conclusion

Intravitreal ranibizumab on a variable-dosing regimen was effective in significantly increasing mean BVCA and reducing CRT. This beneficial outcome was achieved with a low-rate of mild ocular adverse effects among our patients.

Section snippets

Methods

In this prospective study, we enrolled 138 patients with subfoveal CNV secondary to AMD. Before determination of full eligibility, informed consent was obtained from all patients. For inclusion in the study, patients had to be at least 50 years old, have a BCVA of 20/320 to 20/32 (Snellen equivalent) obtained using Early Treatment Diabetic Retinopathy Study (ETDRS) chart, and have primary or recurrent subfoveal CNV attributable to neovascular AMD on 1 or both eyes. If both eyes were eligible, 1

Results

A total of 138 patients (89 female, 49 male) aged from 51 to 94 years (mean, 76.5 ± 8.9 years) were included in the analysis. Patient demographics, previous medical history, and FA characteristics are presented in Table 1. At BL, the main presenting symptom was a decrease in BCVA. It was associated with metamorphopsia in all patients. Inability to read or drive, loss of stereopsis, altered color vision, and flashes of light were common associated symptoms. Mean follow-up time was 24 ± 1.9

Discussion

Our study showed that a variable-dosing regimen of ranibizumab 0.5 mg can be efficient in reducing sub and intraretinal edema (Figure) and significantly improving VA. Consideration of OCT-findings, FA, and clinical signs for the retreatment decision in a monthly reevaluation setting allowed promising results over a period of 24 months.

Improvements in BCVA in the therapy for neovascular AMD were first demonstrated with a fixed-dosing regimen of ranibizumab in the phase III clinical trials ANCHOR

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