Ranibizumab Linked With Extensive Lapses in Care for Proliferative Diabetic Retinopathy

Ranibizumab may be associated with long lapses in care for patients with proliferative diabetic retinopathy (PDR), particularly those with no prior laser treatment for diabetic macular edema (DME). Findings were published this week in JAMA Ophthalmology.

As the first effective therapy for PDR since panretinal photocoagulation (PRP) in 1976, ranibizumab has been shown to provide less visual field loss, lower incidence of vision-impairing DME, fewer vitrectomies, and fewer retinal detachments through 2 years.

However, the greater frequency of treatment and monitoring visits compared with PRP has been noted as a significant barrier to adherence for patients, with anti–vascular endothelial growth factor (VEGF) agents typically requiring 4 to 6 consecutive monthly loading doses followed by frequent examinations.

“Because of the greater need for monitoring and repeat treatment with anti-VEGF therapy, the likelihood that a patient will comply with the follow-up schedule is an important consideration in choosing between treatment approaches,” said researchers. “A high proportion of patients returning after an extended lapse in care had irreversible visual acuity loss and/or vision-threatening disease progression.”

Amid these concerns, they conducted a post hoc analysis of the frequency and pattern of lapses in follow-up among 305 patients with PDR enrolled in the multi-center randomized Protocol S trial. Participant data between February and December 2012 were derived across 55 US sites, with the final 2-year visit completed in January 2015.

In the Protocol S study, a total of 394 study eyes with PDR were treated with either ranibizumab 0.5 mg or PRP. Both eyes were enrolled for 89 participants (1 eye to each study group).

For the current analysis, researchers assessed 170 study eyes of the ranibizumab group (median age at baseline, 51 years; 72.9% self-reported type 2 diabetes) for the primary outcomes of a long lapse in care of 8 or more weeks past a scheduled examination, dropout from follow-up, and visual acuity at 5 years.

Among the cohort, more than half of participants (n = 94 [55.3%]) reported 1 or more long lapse in care through 5 years of follow-up, with median time to the first long lapse indicated as 210 weeks. Of these patients, 73.4% (n = 69) returned for examination after the first long lapse.

Moreover, 50 patients (29.4%) dropped out of follow-up by 5 years. Among those who completed the 5-year examination (n = 120), median change from baseline in visual acuity was −2 letters for participants who had 1 or more long lapse compared with +5 letters for those without a long lapse (P = .02).

“Visual acuity letter scores indicate best-corrected visual acuity in the study eye following protocol-defined refraction. Visual acuity was measured using electronic ETDRS visual acuity testing; higher letter scores indicate better vision,” explained researchers.

After adjusting for potential confounding variables, 1 or more long lapse in care was associated with 3 baseline factors:

• 21% greater risk of 1 or more long lapse in care for each 5-letter decrement in visual acuity score (OR, 1.21; 95% CI, 1.03-1.43)
• 2.1-fold greater risk of 1 or more long lapse in care for neovascularization of the disc and elsewhere (OR, 2.19; 95% CI, 1.09-4.38)
• 3.4-fold greater risk of 1 or more long lapse in care for no prior laser treatment for diabetic macular edema (OR, 3.48; 95% CI, 1.38-8.78)

“Over 5 years, approximately half of the participants assigned to ranibizumab for PDR had a long lapse in care despite substantial effort by the DRCR Retina Network to facilitate timely completion of examinations,” concluded the study authors. “The likelihood of a long lapse in care during long-term follow-up needs to be considered when choosing treatment for PDR.”

Reference

Maguire MG, Liu D, Bressler SB, et al. Lapses in care among patients assigned to ranibizumab for proliferative diabetic retinopathy. JAMA Ophthalmol. Published online October 21, 2021. doi:10.1001/jamaophthalmol.2021.4103