COMMENTARY

Long-term Outcomes of Intravitreal Injections for AMD

Vaidehi S. Dedania, MD; Sophie J. Bakri, MD

Disclosures

June 06, 2014

In This Article

Seven-Year Outcomes in Ranibizumab-Treated Patients in ANCHOR, MARINA, and HORIZON: A Multicenter Cohort Study (SEVEN-UP)

Rofagha S, Bhisitkul RB, Boyer DS, Sadda SR, Zhang K; SEVEN-UP Study Group
Ophthalmology. 2013;120:2292-2299

Intravitreal VEGF Inhibitors for Age-Related Macular Degeneration

The intravitreal injection of an anti-vascular endothelial growth factor (VEGF) agent is the current standard of care for the treatment of neovascular age-related macular degeneration (exudative AMD). Ranibizumab, a monoclonal antibody directed at VEGF-A, has been in wide clinical use for the treatment of exudative AMD since its approval by the US Food and Drug Administration in 2006. The Open-Label Extension Trial of Ranibizumab for Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (HORIZON) was a phase 3b extension trial assessing ranibizumab treatment pro re nata (PRN; as needed) for an additional 2 years among patients who had received monthly ranibizumab for 2 years in the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR), the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA), and the RhuFab V2 Ocular Treatment Combining the Use of Visudyne to Evaluate Safety (FOCUS) trials.

Study Summary

In this multicenter, noninterventional, cross-sectional study, the long-term outcomes of a cohort of 65 patients treated with ranibizumab within the HARBOR study, and originally treated within the ANCHOR and MARINA trials, were evaluated.

Of the 233 patients in the ANCHOR trial and 415 patients in the MARINA trial, 173 and 353, respectively, were assigned to additional treatment with ranibizumab (0.5 mg PRN) in the HORIZON trial, with 357 completing 24 months of participation. In the SEVEN-UP cohort study, 65 of the 155 patients who completed the HORIZON trial and met inclusion criteria were enrolled. These patients returned for a single reassessment 7-8 years after initial enrollment in the ANCHOR and MARINA trials.

The ETDRS vision at baseline (upon entry into the MARINA and ANCHOR trials) and at the completion of the MARINA or ANCHOR trials and the HORIZON study were obtained from the original databases. The number of intravitreal injections with anti-VEGF agents (ranibizumab and/or bevacizumab) or other AMD treatments (photodynamic therapy, corticosteroids, thermal laser, or other investigational treatment) was obtained from retrospective chart review of the interval following exit from the HORIZON study. Patient medical records were reviewed for evidence of choroidal neovascularization (CNV) activity in the 6 months before entering the SEVEN-UP trial. An interval history was collected for 63 of the 65 patients.

The primary outcome was the proportion of patients with Snellen equivalent best-corrected visual acuity (BCVA) of 20/70 or better in the study eye. Secondary outcomes included:

  • The percentage of eyes with good vision (20/40 or better);

  • The percentage of eyes with poor vision (20/200 or worse);

  • The percentage of eyes with disease quiescence; and

  • Anatomic results on fluorescein angiography, spectral-domain optical coherence tomography (OCT), and fundus autofluorescence (FAF).

The SEVEN-UP assessment was performed an average of 3.4 years after exit from the HORIZON study and 7.3 years after initial entry into the ANCHOR or MARINA trials. Although the cohort enrolled in the SEVEN-UP study had a higher nonwhite proportion of patients, no significant differences in age, sex, initial ranibizumab dose assignment, eye laterality, baseline BCVA, CNV lesion subtype, or total area of CNV leakage at baseline were found between the SEVEN-UP sample and the total cohort from which it was drawn.

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