COMMENTARY

Long-term Outcomes of Intravitreal Injections for AMD

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

Disclosures

June 06, 2014

In This Article

Study Findings

The primary endpoint (BCVA of 20/70 or better) was achieved in 24 of the 65 study eyes (37%). In consideration of the secondary endpoints, 23% had BCVA of 20/40 or better, and 37% had BCVA of 20/200 or worse (legally blind) in the study eye. A mean loss of 8.6 ETDRS letters (P < .005) from baseline to the SEVEN-UP assessment and of 19.8 letters (P < .0001) from therapeutic peak upon completion of the ANCHOR and MARINA trials was found (Table 1). Stable or improved ETDRS letter score (≥ 0 letter gain) from baseline was found in 43.1% of study eyes, with a gain of ≥ 15 letters from baseline in 12.3% and a loss of ≥ 15 letters in 33.8% (Table 2). At the SEVEN-UP assessment, 98.2% of study eyes had central macular atrophy on FAF.

Table 1. SEVEN-UP Study Findings Summary

Endpoint Findings
Patients with Snellen BCVA ≥ 20/70 37%
Patients with Snellen BCVA ≥ 20/40 23%
Mean change from baseline (ETDRS letters) -8.6
Mean change since completion of ANCHOR or MARINA (ETDRS letters) -19.8
Mean change since completion of HORIZON* (ETDRS letters) -6.9

*Of the 50 patients with data available at month 24. BCVA = best corrected visual acuity

Table 2. Visual Outcomes (ETDRS Letters) Relative to Baseline, Exit From ANCHOR or MARINA, and Exit From HORIZON

Endpoint Comparison
Baseline Exit From ANCHOR or MARINA Month 24 of HORIZON*
Patients gaining ≥ 0 letters (%) 43.1 15.4 32
Patients gaining ≥ 15 letters (%) 12.3 3.1 2
Patients losing ≥ 15 letters (%) 33.8 16.9 22

*Of the 50 patients with data available at month 24.

In the interval between exit from the HORIZON study and the SEVEN-UP assessment, 641 intravitreal anti-VEGF injections (494 ranibizumab and 147 bevacizumab), a mean of 6.8 injections per eye, were administered to the 62 patients whose charts were available for review. Eleven or more injections were administered to 23% of eyes, and 43% did not receive any additional injections. Eyes receiving 11 or more injections were more likely to gain vision in the interval after exiting from the HORIZON study, with an average gain of 3.9 letters (P < .05).

At the SEVEN-UP visit and in the preceding 6 months, 46% of study eyes had undergone intravitreal anti-VEGF injection, with reports of exudation in 80% of these eyes. In a query of investigators about current and recent treatments, 18 patients (28%) were deemed to have active exudation, and 15 study eyes (23%) were indicated for anti-VEGF injection. Of the 18 patients with active exudation, an indication for anti-VEGF injection at the SEVEN-UP visit was deemed necessary in 8 patients. A portion of patients without active exudation received treatment at the SEVEN-UP visit, possibly indicating that some patients were maintained on a treat-and-extend protocol, in which treatment was administered independent of active exudation.

Imaging was performed in 60 patients at the SEVEN-UP assessment. Fluorescein angiography was performed in 56 patients, of which 27 (48%) had definite or questionable CNV leakage. Furthermore, macular subretinal or intraretinal heme was documented on fundus photography in 14 of 57 eyes (24.1%). Although evidence of CNV (P < .80), presence of leakage (P < .40), and total area of CNV leakage (P < .70) were not associated with BVCA at the SEVEN-UP visit, total area of lesion and nonlesion components (P < .001) was significantly associated with BCVA. No statistically significant difference in visual outcomes was found between eyes with and without exudation on OCT (P < .30). Similarly, mean foveal thickness (P < .15), mean retinal thickness in the central subfield (P < .45), mean central point thickness (P < .95), and total retinal thickness at the foveal center point (P < .80) were not statistically significantly associated with BCVA at the SEVEN-UP visit. Increased area of macular atrophy (P < .0001) and the presence of subfoveal macular atrophy (P < .01) on FAF were associated with lower BCVA, with a 2.3-letter reduction in BCVA for every 1-mm2 increase in macular atrophy (P < .0001).

Upon entry into the ANCHOR and MARINA trials, 46% of patients had bilateral exudative AMD; and at the SEVEN-UP visit, 51% of patients were diagnosed with bilateral disease.

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