Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab

• Status: Withdrawn
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast Clinical Research Associates, LLC
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; Ranibizumab

Criteria

Inclusion Criteria:

• Age ≥18 years with type 1 or type 2 diabetes

• Best Corrected Visual Acuity (by ETDRS) letter score in study eye ≤ 85 and ≥24 (approximate Snellen equivalent 20/20 to 20/320)

• Central retinal thickness on SD OCT at baseline visit of > 300 microns using Heidelberg Spectralis with definite evidence of intraretinal or subretinal fluid due to diabetic retinopathy in the CSF.

• Patients must have received at least four intravitreal ranibizumab 0.3 mg injections within 24 weeks prior to screening and failed to have had complete resolution of intraretinal or subretinal fluid on SD OCT and a CRT > 300 microns using Heidelberg Spectralis

Exclusion Criteria:

• Laser photocoagulation (panretinal or macular) in the study within 90 days of baseline

• Active high risk proliferative diabetic retinopathy (PDR)

• History of intravitreal corticosteroids within 4 months of baseline

• History of intravitreal bevacizumab within 24 weeks of baseline

• History of idiopathic or autoimmune uveitis in the study eye

• Cataract surgery in the study eye within 90 days of baseline

• Any intraocular surgery within 90 days of baseline

• Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision

• Evidence of active infection in either eye

• Uncontrolled glaucoma in the study eye defined as a pressure of > 25 mmHg on maximal medical therapy.