蜜芽app

According to a study published in the American Journal of Ophthalmology, visual and anatomic findings are usually stable after suspension of treatment for advanced neovascular age-related macular degeneration (nAMD) with vision 鈮�20/400.¹

Previous studies have suggested that anti-vascular endothelial growth factor (anti-VEGF) treatment may not improve visual acuity in many patients with advanced nAMD.^2,3 Anti-VEGF treatment is often suspended for these non-responders. 

鈥淥verall, patients benefit greatly from anti-VEGF medications,鈥� Sunir J. Garg, MD, of The Retina Service of Wills Eye Hospital in Philadelphia, PA, and co-author of the new study, told 蜜芽app. 鈥淭here are reasons that a patient may stop treatment, including other health issues, trouble getting to the office, or perceived lack of benefit from treatment.鈥� 

In an interview with 蜜芽app, the study鈥檚 senior author, Jason Hsu, MD, of the Sidney Kimmel Medical College of Thomas Jefferson University and also of The Retina Service of Wills Eye Hospital in Philadelphia, PA, said, 鈥淲e often see patients who have gradually lost central vision due to progressive macular atrophy or disciform scarring. The question I had was whether it was safe to stop anti-VEGF therapy in these patients or would they relapse due to recurrent exudation.鈥�

Dr. Hsu said, 鈥淢y clinical experience had been that some of these patients would ask me whether it would be reasonable to stop treating as they were not seeing any benefit of continuing the injections. In many of those cases where we stopped, it seemed that their lesions typically remained very stable, and they rarely seemed to complain of further worsening.鈥� 

This observation of lesion stability in patients with advanced disease is supported by a study of treatment suspension in 470 eyes, which found that lesion reactivation was less common in those with worse visual acuity at the time of suspension than those with good or intermediate visual acuity.⁴

To understand the consequences of treatment suspension in patients with poor vision in nAMD, investigators in this study analyzed changes in visual acuity and lesion size in those who suspended anti-VEGF treatment.

Patients

The study design was a retrospective study of patient records at The Retina Service of Wills Eye Hospital and offices of Wills Eye Physicians-Mid Atlantic Retina. 

The inclusion criteria were diagnosis and treatment of nAMD, visual acuity 鈮�20/400 at the time of the first anti-VEGF treatment for nAMD (baseline), at least 3 anti-VEGF treatments within the previous 6 months before suspending treatment for 6 months or longer, and suspension of treatment upon physician recommendation. All patients who met the criteria from January 4, 2013, to October 1, 2021, were included. The rationale for the vision cut-off was that patients with vision 鈮�20/320 were included in prior clinical trials, so little is known about the cohort being observed in this study. 

Patients underwent visual acuity exams and optical coherence tomography at baseline and every 6 months after treatment suspension for 24 months. 

Restarting anti-VEGF treatment within 24 months of suspension was the primary outcome. Changes in visual acuity, lesion size, and central foveal thickness were secondary outcomes.

Baseline 

The study included 93 eyes from 93 patients with a mean age of 81 卤 8.3 years. At the time of the first anti-VEGF treatment, the logarithm of the minimum angle of resolution (LogMAR VA) was 1.26 卤 0.67 or Snellen visual acuity 20/364. 

At the first anti-VEGF injection, 30% of eyes had hemorrhage, 30% had intraretinal fluid, and 59% had subretinal fluid.

Treatment to suspension

The mean time of anti-VEGF treatment before suspension was 962 卤 562 days, with a mean of 16 卤 10 injections. 

At the time of suspension, visual acuity significantly worsened compared to the time of the first anti-VEGF treatment. The mean LogMAR VA was 1.87 卤 0.32 or Snellen 20/1482 at suspension (P<.001). 

The greatest mean lesion diameter did not change significantly between the first anti-VEGF treatment (2350 卤 1314 碌m) to suspension (2547 卤 1294 碌m; P=.50).

However, the greatest mean lesion thickness was reduced from 247 卤 200 碌m at the time of the first anti-VEGF injection to 194 卤 135 碌m (P=.005) at suspension. The mean central foveal thickness was also decreased from 222 卤 125 碌m at treatment initiation to 161 卤 118 碌m at suspension (P<.001).

At suspension, 44% of eyes had active lesions, and 45% had geographic atrophy.

Suspension to follow-up

The proportion of patients who completed follow-up visits declined from 92% of patients at 6 months to 56% at 24 months after suspension.

Compared with the time of treatment suspension, the mean LogMAR VA was significantly worse at 6 months (1.95 卤 0.33; Snellen, 20/1782; P=.03) and 12 months (1.96 卤 0.35; Snellen, 20/1824; P=.03) after treatment suspension. However, visual acuity at the 18- and 24-month follow-up visits was not significantly different from the time of suspension. 

Most other parameters were stable after suspension. Anatomic measurements (mean greatest lesion diameter or thickness, mean central foveal thickness) were not different from the time of treatment suspension at 6-, 12-, 18-, or 24-month follow-up visits, except for a slight increase in mean greatest lesion thickness at 12-months.

In contrast, the proportion of eyes with intraretinal fluid decreased from 61.3% at the time of treatment suspension to 41.9% at 6 months post-suspension (P<.001) and was stable thereafter.

A few patients restarted anti-VEGF treatment at a mean of 977 卤 450 days after suspension. Two patients resumed treatment within the 24-month follow-up period, and 5 others resumed treatment afterward. The causes for resuming treatment were new retinal hemorrhage in 2 eyes and active choroidal neovascularization in 5 eyes.

Which patients?

鈥淥ur study suggests that pausing anti-VEGF injections in patients with advanced wet AMD with 20/400 or worse vision is not unreasonable and generally did not appear to be detrimental,鈥� said Dr. Hsu. 鈥淗owever, a small number of patients may have recurrent exudation that warrants restarting therapy. Therefore, even if treatment is halted, these patients still benefit from regular monitoring,鈥� he added.

The investigators cautioned that their study does not mean all patients with advanced disease and a poor response to treatment should suspend treatment. 鈥淚 think each patient must be treated on an individual basis,鈥� said Dr. Hsu. 鈥淪topping anti-VEGF therapy must be a conversation between the patient and treating physician. In some patients who have advanced wet AMD and poor vision, stopping therapy may not be a good idea, especially if it is their better-seeing eye, as any decrease in vision may have significant impacts on their activities of daily living and sense of well-being.鈥�

Furthermore, Dr. Garg told 蜜芽app that there were some limitations to the study that physicians should note: 鈥淭he people who choose to stop treatment may be different than other people. Perhaps they had longstanding vision loss, or maybe they had a bad bleed in the eye, or perhaps their other eye sees well. These patients may be different than those in the study.鈥� 

鈥淭he other issue is that visual acuity is an imperfect way of representing visual functioning and is particularly variable at the worst levels,鈥� explained Dr. Hsu. 鈥淲hile we found a slight decrease in vision after stopping anti-VEGF therapy, patients were generally in the counting fingers range, so it is difficult to determine how accurate this was. More importantly, we don鈥檛 know how this impacts the patients鈥� visual functioning on a day-to-day basis and whether it is significant or not.鈥�

Dr. Garg added that 鈥渧ision on the eye chart is not the same as quality of vision in daily life, and although the vision on the eye chart might be the same, there may be some loss of quality of vision at home.鈥�

Other limitations of the study include potential bias in recommendations among physicians, non-standardization of visual acuity measurements, and high loss of patients during follow-up.

For future studies, Dr. Hsu said, 鈥淚t would be great to have confirmation of our findings using larger patient databases.鈥�

Published: October 24, 2023