Original article
An Optical Coherence Tomography-Guided, Variable Dosing Regimen with Intravitreal Ranibizumab (Lucentis) for Neovascular Age-related Macular Degeneration

https://doi.org/10.1016/j.ajo.2007.01.028Get rights and content

Purpose

To evaluate an optical coherence tomography (OCT)-guided, variable-dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD).

Design

Open-label, prospective, single-center, nonrandomized, investigator-sponsored clinical study.

Methods

In this two-year study, neovascular AMD patients with subfoveal choroidal neovascularization (CNV) (n = 40) and a central retinal thickness of at least 300 μm as measured by OCT were enrolled to receive three consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes was observed between visits: a loss of five letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new-onset classic CNV, new macular hemorrhage, or persistent macular fluid detected by OCT at least one month after the previous injection of ranibizumab.

Results

At month 12, the mean visual acuity improved by 9.3 letters (P < .001) and the mean OCT central retinal thickness decreased by 178 μm (P < .001). Visual acuity improved 15 or more letters in 35% of patients. These visual acuity and OCT outcomes were achieved with an average of 5.6 injections over 12 months. After a fluid-free macula was achieved, the mean injection-free interval was 4.5 months before another reinjection was necessary.

Conclusion

This OCT-guided, variable-dosing regimen with ranibizumab resulted in visual acuity outcomes similar to the Phase III clinical studies, but required fewer intravitreal injections. OCT appears useful for determining when retreatment with ranibizumab is necessary.

Section snippets

Methods

PrONTO is a two-year, open-label, prospective, single-center clinical study designed to investigate the efficacy, durability, and safety of a variable dosing regimen with intravitreal ranibizumab in patients with neovascular AMD. The PrONTO Study is an investigator sponsored trial supported by Genentech, Inc, and performed with the approval of the Food and Drug Administration. Before the initiation of the study, additional approval for the PrONTO study was obtained from the Institutional Review

Baseline Characteristics

Between August 2004 and April 2005, 69 patients were screened for the study and 40 patients were enrolled. Twenty-nine patients were excluded from the study for the following reasons: OCT central retinal thickness less than 300 μm (nine patients), declined participation in the study after screening because of the rigorous follow-up schedule (seven patients), visual acuity either better than 20/40 or worse than 20/400 (four patients), inability to obtain reproducible OCT central retinal

Discussion

In the PrONTO study, intravitreal injections of ranibizumab were shown to rapidly reduce the amount of macular fluid in eyes of patients with neovascular AMD while improving visual acuity. Within one day, both the mean and median OCT central retinal thickness measurements decreased significantly, and by day 14, both the mean and median visual acuity measurements had improved. Continued improvements were evident within the first 3 months after the three scheduled ranibizumab injections and these

Anne E. Fung, MD, graduated with honors in Chinese Studies and Economics from Wellesley College in 1993 and received her MD from Cornell University Medical College in 1999. After completing residency at Stanford University, she pursued a research fellowship at the Smith Kettlewell Eye Research Institute. In 2005, she completed a Medical Retina fellowship at the Bascom Palmer Eye Institute and returned to San Francisco to join her father at Pacific Eye Associates/California Pacific Medical

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Anne E. Fung, MD, graduated with honors in Chinese Studies and Economics from Wellesley College in 1993 and received her MD from Cornell University Medical College in 1999. After completing residency at Stanford University, she pursued a research fellowship at the Smith Kettlewell Eye Research Institute. In 2005, she completed a Medical Retina fellowship at the Bascom Palmer Eye Institute and returned to San Francisco to join her father at Pacific Eye Associates/California Pacific Medical Center where she continues clinical research in age-related macular degeneration.

Geeta A. Lalwani, MD, is currently a surgical retina fellow at the Bascom Palmer Eye Institute in Miami, Florida. She received an AB from Smith College, and an MD from the MCP-Hahnemann School of Medicine, where she was elected into the Alpha Omega Alpha honor society. She will complete her fellowship in July 2007.

See accompanying Editorial on page 679.

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