NCT01988246.

Trial name or title	PROMISE
Methods	Prospective, randomised, controlled, single‐masked (participant) study
Participants	Prevention of macular oedema in participants with diabetic retinopathy undergoing cataract surgery
Interventions	Aflibercept 2 mg intravitreal injection (0.05 mL or 50 μL) administered at time of surgery (post cataract excision) versus sham injection
Outcomes	Primary: Safety and efficacy at day 90 Incidence and severity of ocular and non‐ocular adverse events and serious adverse events between treatment arms Secondary: Visual acuity at day 90 Change from baseline in BCVA score at day 90 as measured by ETDRS Macular oedema at day 90 Macular oedema as measured by spectral domain ocular coherence tomography at day 90
Starting date	December 2013
Contact information	Rishi Singh, M.D.; mail: singhr@ccf.org Gail Kolin, BSN RN; mail: koling@ccf.org
Notes	There will be participants with non‐proliferative diabetic retinopathy

BCVA: best‐corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; PRP: panretinal photocoagulation; VEGF: vascular endothelial growth factor.