Intravitreal Injections of Ziv-aflibercept for Macular Diseases

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic macular edema (DME), wet-AMD and macular edema secondary to vein occlusions are the leading cause of blindness in developed countries. Several therapies have been studied as such laser treatment and intravitreal injections of corticosteroids or anti-VEGF drugs. In terms of public health the long term treatment with the current available drugs is very expensive and new therapies with the same or better effect should be investigated. This study intends to evaluate the efficacy and safety of intravitreal injections of ziv-aflibercept for the treatment of patients with DME, wet-AMD and macular edema secondary to vein occlusions.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retina Clinic, Sao Paulo, Brazil
• Collaborator: Federal University of São Paulo
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus

• BCVA varying from 20/62 to 20/400 (Snellen chart) - equivalent 0.49 to 1.30 logMAR - caused by DME

• Central Retinal Thickness on OCT (Heildelberg Engineering, Heidelberg, Germany ) of 275 mm or more

Exclusion Criteria:

• Laser photocoagulation within the previous 6 months

• Previous intraocular anti-VEGF or corticosteroid injection

• Previous systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy

• Vitreomacular traction or epiretinal membrane producing any traction on the macula on SD-OCT scan

• Angiographic evidence of macular ischemia defined as foveal avascular zone greatest linear dimension of more than 1000 mm or severe perifoveal capillary loss

• Previous cataract, trabeculectomy or vitrectomy

• Aphakia

• External ocular infections

• Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)

• Likelihood of needing intraocular surgery within 6 months

• Proliferative diabetic retinopathy with any evidence of retinal traction

• Systemic conditions that precluded trial enrollment included glycosylated hemoglobin of more than 10.0%

• Past medical history of chronic renal failure requiring either dialysis or kidney transplantation

• Blood pressure of more than 160/90 mmHg

• an arteriothrombotic event within 6 months before randomization, including myocardial infarction, acute congestive heart failure or other cardiac event, and stroke or transient ischemic attack

• Pregnancy or breastfeeding.