Retreatment needs of patients with proliferative diabetic retinopathy treated with ranibizumab, laser or combination therapy

Abstract

Purpose : To investigate retreatment rates after 1 year of ranibizumab, panretinal laser photocoagulation (PRP) or combination therapy in patients with proliferative diabetic retinopathy (PDR) in the PRIDE study.

Methods : The PRIDE study (NCT01594281) is a Phase II, multicenter, open-label but central reading center-blinded, randomized, controlled study evaluating treatment of patients with PDR with no macular edema. Patients were randomized 1:1:1 to the three treatment arms and treated as needed for 12 months in the core phase of the study (full analysis set: n=106). Thereafter, patients were followed-up observationally in a non-interventional follow-up period with two visits at Month 18 and 24 to assess further outcomes and whether additional treatment was required. 73 patients of the initially enrolled population were included in the analysis of the observational second year follow-up with treatment at the investigators discretion.

Results : In the first year of the study, patients in the ranibizumab and combination group received 3 initial injections followed by 2.3 ± 2.1 or 2.1 ± 2.1 additional injections (mean ± SD), respectively. Patients in the combination group were treated with 1,670 ± 568 laser spots, patients in the PRP group with 1,919 ± 673 laser spots (mean ± SD). In the observational second year, 68% of the patients in the ranibizumab group (n=28) received – at the investigators discretion - PRP treatment (all of them for PDR) and 7% anti-VEGF injections (1 patient for DME, 1 for PDR). In the combination group (n=25), 48% of the patients received PRP (1 for DME, 11 for PDR) and 32% anti-VEGF medication (4 for DME, 3 for PDR, 1 for post-cataract prophylaxis). In the former PRP group (n=20), 40% of the patients received additional PRP (1 for DME, 1 for hemorrhage, 6 for PDR) and 30% anti-VEGF injections (5 for DME, 1 for PDR) in the second year.

Conclusions : Observational follow-up data from the PRIDE study show that PDR often requires continuous treatment beyond the first year either with anti-VEGF, laser therapy or a combination of both. At investigators' discretion, laser treatment was used more frequently in patients who received no PRP treatment in the first year, whereas anti-VEGF was used more frequently in the PRP or combination pre-treatment group than in the ranibizumab monotherapy pre-treatment group.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.