In a single-blind, non-inferiority trial it has been found that patients with proliferative diabetic retinopathy who were treated with intravitreal aflibercept had an improved outcome at 1 year compared with those treated with panretinal laser photocoagulation PRP standard care.
Proliferative diabetic retinopathy is the most common cause of severe sight impairment in people with diabetes. Proliferative diabetic retinopathy has been managed by panretinal laser photocoagulation (PRP) for the past 40 years. Although laser technology and techniques have evolved over the past decade to reduce side-effects, approximately 4·5% progress to require vitrectomy surgery.Therefore, there is a substantial unmet need for novel treatments that reduce the risk of severe visual loss in PDR that is non-inferior to PRP with fewer side-effects.
Dr.S.Sivaprasad and associates studied 1-year safety and efficacy of intravitreal aflibercept in Proliferative diabetic retinopathy.The researchers in this phase 2b, single-blind, non-inferiority trial (CLARITY) recruited adults (aged ≥18 years) with type 1 or 2 diabetes and previously untreated or post-laser treated active proliferative diabetic retinopathy were from 22 UK ophthalmic centers.Patients were randomly assigned (1:1) to repeated intravitreal aflibercept (2 mg/0·05 mL at baseline, 4 weeks, and 8 weeks, and from week 12 patients were reviewed every 4 weeks and aflibercept injections were given as needed) or PRP standard care (single spot or multisport laser at baseline, fractionated fortnightly thereafter, and from week 12 patients were assessed every 8 weeks and treated with PRP as needed) for 52 weeks.No patients in the aflibercept group developed vitreous hemorrhage that required exclusion from the model at 12 weeks.
It was found that Aflibercept was non-inferior and superior to PRP in both the modified intention-to-treat population (mean best-corrected visual acuity difference 3·9 letters [95% CI 2·3-5·6], p<0·0001) and the per-protocol population (4·0 letters [2·4-5·7], p<0·0001)
It was concluded that Aflibercept was non-inferior and superior to panretinal laser photocoagulation in both the modified intention-to-treat population and the per-protocol population. These findings should be taken into consideration when formulating a treatment management plan for individuals with proliferative diabetic retinopathy.
For more details click on the link: DOI: http://dx.doi.org/10.1016/S0140-6736(17)31193-5